Progress: Procedure lapsed or withdrawn
Role | Committee | Rapporteur | Shadows |
---|---|---|---|
Lead | IMCO | ||
Committee Opinion | ITRE | Sajjad KARIM ( ECR) | |
Committee Opinion | ECON | ||
Committee Opinion | INTA | ||
Committee Opinion | JURI | ||
Committee Opinion | ENVI |
Lead committee dossier:
Legal Basis:
TFEU 114-p1
Legal Basis:
TFEU 114-p1Subjects
- 2.10.03 Standardisation, EC/EU standards and trade mark, certification, compliance
- 3.45.08 Business environment, reduction of the administrative burdens
- 4.60.08 Safety of products and services, product liability
- 6.20.02 Export/import control, trade defence, trade barriers
- 6.20.04 Union Customs Code, tariffs, preferential arrangements, rules of origin
- 8.50.02 Legislative simplification, coordination, codification
Events
The European Parliament adopted by 485 votes to 130 with 27 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council on consumer product safety and repealing Council Directive 87/357/EEC and Directive 2001/95/EC.
Parliament adopted its position at first reading following the ordinary legislative procedure, and amend the Commission proposal as follows:
Purpose of the Regulation : the Regulation should aim in to ensure the functioning of the internal market and contributing to protecting the health and safety of consumers. The provisions of the Regulation are based on the precautionary principle , and the Regulation applies to the online market .
However, it will not apply to second-hand products originally placed on the market before the entry into force of the Regulation.
A ‘safe product' is defined any authentic product which is compliant with Union harmonisation legislation for health and safety. The notion of a 'product model' , cornerstone of the work of market surveillance authorities, is introduced.
‘Serious risk’ means any serious risk, including those the effects of which are not immediate, requiring rapid intervention by the public authorities.
Food-imitation products : the marketing, import, manufacture and export of products that, although not foodstuffs, resemble foodstuffs and are likely to be confused with foodstuffs must be prohibited .
Factors related to evaluating the safety of a product : Parliament called for the required the characteristics of the product to be taken into account, including its authenticity ; the characteristics of consumers at risk when using the product under reasonably foreseeable conditions, in particular vulnerable consumers ; the fact that the product resembles an object commonly recognised as appealing to children .
The evaluation must also bear in mind reasonable consumer expectations concerning safety in terms of the nature, composition and intended use of the product; the essential requirements contained in the standardisation requests to European standardisation organisations; whether the product, categories or groups of products, have caused injuries notified into the Pan-European Injury Database.
Identification of the origin : Parliament proposed that the manufacturers should be authorised to indicate the country of origin in English alone (‘Made in [country]’), since this is readily comprehensible for consumers.
Obligations of economic operators : the amended text strengthened these obligations by introducing the following provisions, amongst other things:
Proportionate to the possible risks presented by a product, manufacturers or importers should carry out at least once a year representative sample testing of a randomly selected product made available on the market chosen under the control of a judicial officer.
Manufacturers should: (i) keep the technical documentation in paper or electronic form at the disposal of the market surveillance authorities and provide it to those authorities, upon reasoned request; (ii) ensure that their product is accompanied by instructions and safety information addressed to the consumer in a clear and comprehensible manner; (iii) ensure that they have procedures in place for taking corrective action, withdrawing or recalling their products; (iv) warn consumers who are at risk caused by the non-conformity of the product.
Distributors should not obscure any compulsory information or safety-related information provided by the manufacturer or importer. In order to protect the health and safety of consumers, they should carry out at least once a year representative sample testing of products made available on the market chosen under the control of a judicial officer or any qualified person designated by each Member State.
Product Safety Contact Points: Member States should designate Product Safety Contact Points in their territories and shall communicate their contact details to the other Member States and to the Commission. Members proposed to broaden the scope of the Product Contact Points by facilitating training on product safety legislation and transfer information across industries and to the economic operators.
Product Safety Contact Points should provide information on the remedies generally available in the territory of that Member State in the event of a dispute between the competent authorities and an economic operator. They should respond within 15 working days of receiving any request.
Penalties: penalties should take into account: (i) the seriousness, the duration and, where applicable, the intentional character of the infringement; (ii) whether the relevant economic operator has previously committed a similar infringement.
Administrative penalties applicable to infringements should at least offset the economic advantage sought through the infringement , but shall not exceed 10 % of the annual turnover or an estimate thereof. They may be higher than 10 % of the annual turnover, where necessary to offset the economic advantage sought through the infringement. The penalties could include criminal sanctions for serious infringements.
The Committee on the Internal Market and Consumer Protection adopted the report by Christel SCHALDEMOSE (S&D, DK) on the proposal for a regulation of the European Parliament and of the Council on consumer product safety and repealing Council Directive 87/357/EEC and Directive 2001/95/EC
The committee recommends that Parliament adopt its position in first reading following the ordinary legislative procedure, and amend the Commission proposal as follows:
Purpose of the Regulation : the Regulation should aim in to ensure the functioning of the internal market and contributing to protecting the health and safety of consumers. The provisions of the Regulation are based on the precautionary principle , and the Regulation applies to the online market .
However, it will not apply to second-hand products originally placed on the market before the entry into force of the Regulation.
A ‘safe product' is defined any authentic product which is compliant with Union harmonisation legislation for health and safety. The notion of a 'product model' , cornerstone of the work of market surveillance authorities, is introduced.
‘Serious risk’ means any serious risk, including those the effects of which are not immediate, requiring rapid intervention by the public authorities.
Food-imitation products : the marketing, import, manufacture and export of products that, although not foodstuffs, resemble foodstuffs and are likely to be confused with foodstuffs must be prohibited.
Factors related to evaluating the safety of a product : the report required the characteristics of the product to be taken into account, including its authenticity; the characteristics of consumers at risk when using the product under reasonably foreseeable conditions, in particular vulnerable consumers ; the fact that the product resembles an object commonly recognised as appealing to children .
Evaluation must also bear in mind: reasonable consumer expectations concerning safety in terms of the nature, composition and intended use of the product; the essential requirements contained in the standardisation requests to European standardisation organisations; whether the product, categories or groups of products, have caused injuries notified into the Pan-European Injury Database.
‘EU Safety Tested’ marking : Members proposed to put in place a new CE marking certifying that the product had been tested by an independent third party and found safe by a competent body.
The new ‘EU Safety Tested’ marking will be complementary to the current CE marking.
Obligations of economic operators : the amended text strengthened these obligations by introducing the following provisions, amongst other things:
· Proportionate to the possible risks presented by a product, manufacturers or importers shall carry out at least once a year representative sample testing of a randomly selected product made available on the market chosen under the control of a judicial officer.
· Manufacturers must: (i) keep the technical documentation in paper or electronic form at the disposal of the market surveillance authorities and provide it to those authorities, upon reasoned request; (ii) ensure that their product is accompanied by instructions and safety information addressed to the consumer in a clear and comprehensible manner; (iii) ensure that they have procedures in place for taking corrective action, withdrawing or recalling their products; (iv) warn consumers who are at risk caused by the non-conformity of the product.
· Distributors shall not obscure any compulsory information or safety-related information provided by the manufacturer or importer.
Product Safety Contact Points: Member States shall designate Product Safety Contact Points in their territories and shall communicate their contact details to the other Member States and to the Commission.
Members proposed to broaden the scope of the Product Contact Points by facilitating training on product safety legislation and transfer information across industries and to the economic operators.
Penalties: penalties must take into account: (i) the seriousness, the duration and, where applicable, the intentional character of the infringement; (ii) whether the relevant economic operator has previously committed a similar infringement.
Administrative penalties applicable to infringements shall at least offset the economic advantage sought through the infringement , but shall not exceed 10 % of the annual turnover or an estimate thereof. They may be higher than 10 % of the annual turnover, where necessary to offset the economic advantage sought through the infringement. The penalties may include criminal sanctions for serious infringements.
PURPOSE: to ensure the functioning of the internal market as regards products intended for consumers by laying down uniform rules regarding a general safety requirement (product safety and market surveillance package).
PROPOSED ACT: Regulation of the European Parliament and of the Council (repealing Council Directive 87/357/EEC and Directive 2001/95/EC on general product safety).
ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.
BACKGROUND: the free movement of safe consumer products is one of the cornerstones of the European Union. Directive 2001/95/EC on general product safety (GPSD) lays down the requirement that consumer products must be safe and that Member States' market surveillance authorities must take action against dangerous products as well as exchange information to that effect through the Community rapid information exchange system RAPEX.
Overlaps of market surveillance rules and obligations of economic operators laid down in various pieces of Union legislation (the GPSD, the Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and sector-specific Union harmonisation legislation that also covers consumer products) has led to confusion on the part of both economic operators and national authorities and has seriously hampered the effectiveness of market surveillance activity in the Union.
The Commission considers that Directive 2001/95/EC needs to be fundamentally revised to improve its functioning and to ensure consistency with developments in Union legislation as regards market surveillance, obligations of economic operators and standardisation. In the interest of clarity, Directive 2001/95/EC should be repealed and replaced by this Regulation.
The proposal is part of the " Product Safety and Market Surveillance Package " which also includes a proposal for a single market surveillance regulation and a multiannual action plan for market surveillance covering the period 2013-2015 . The Single Market Act II , adopted in 2012, confirms the "Product Safety and Market Surveillance Package" as a key action to improve the safety of products circulating in the EU.
IMPACT ASSESSMENT: the impact assessment prepared by the Commission thus covers aspects related to both this proposal and the proposal for a new Market Surveillance Regulation. The Commission's Impact Assessment Board delivered a favourable opinion in September 2012.
LEGAL BASIS: Article 114 of the Treaty on the Functioning of the European Union.
CONTENT: this proposal for a Regulation on consumer product safety , which will replace Directive 2001/95/EC on general product safety (GPSD), concerns manufactured non-food consumer products . It aims at clarifying the regulatory framework for consumer products taking into account legislative developments in recent years.
Like the GPSD, the proposed Regulation requires that consumer products must be "safe", sets certain obligations on economic operators and contains provisions for the development of standards in support of the general safety requirement.
The main elements of the proposal are as follows:
Scope and definitions : the proposed Regulation clearly delimits its scope of application compared to sectoral Union harmonisation legislation .
Whilst the general principle that all non-food consumer products must be safe applies across the board, the more detailed obligations on economic operators only apply to those operators that are not subject to corresponding obligations laid down in harmonising legislation covering a specific product sector. The definitions section has been updated and, where applicable aligned with the New Legislative Framework for the Marketing of Products.
General safety requirement and obligations of economic operators : the general requirement, laid down already in the GPSD, that all consumer products must be safe when placed or made available on the Union market has been kept. However, its operation in practice will be significantly simplified due to the introduction of a clear link with sector-specific legislation and a simplification of the rules on standards.
On the basis of Decision No 768/2008/EC on a common framework for the marketing of products, the proposal:
lays down the elementary obligations of economic operators (manufacturers, importers, distributors) involved in the supply chain of consumer products insofar as they are not subject to corresponding requirements under sector specific Union harmonisation legislation. These obligations concern issues related to labelling, product identification, corrective actions to be taken in case of unsafe products and information of the competent authorities; requires economic operators to be able to identify the operators who supplied them with the product and to whom they supplied it. Where justified due to the risks inherent to specific types of products, the Commission should be empowered to adopt measures requiring economic operators to establish or adhere to an electronic traceability system.
Use of European standards : like the GPSD, also the proposal for the new Regulation favours the use of standards in support of the implementation of the general safety requirement. However, the process to identify existing European standards or to ask for the development of European standards that would give rise to presume that a product is safe has been significantly simplified and aligned to Regulation (EU) No 1025/2012 that sets a new overarching framework for European standardisation.
Market surveillance and RAPEX : the provisions regarding market surveillance and RAPEX that are currently contained in the GPSD have been transferred to the proposal for a new single Market Surveillance Regulation . That new Regulation would produce a one-tier system in which all market surveillance rules are brought together in a single instrument and in which RAPEX will be the single alert system regarding products presenting a risk.
BUDGETARY IMPLICATION: the proposal does not have other budgetary implications than those related to the proper management of the Regulation which, in form of the GPSD, is already part of the Union law acquis. The budgetary implications are already foreseen in the existing or proposed programmes and respect the Commission proposal for the new multiannual financial framework.
According to the financial statement, the total appropriations (operational appropriations, human resources and administrative expenditure) amount to EUR 12 019 million in commitments for 2015-2020 .
DELEGATED ACTS: the proposal contains provisions empowering the Commission to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union.
Documents
- Debate in Council: 3353
- Commission response to text adopted in plenary: SP(2014)471
- Results of vote in Parliament: Results of vote in Parliament
- Debate in Parliament: Debate in Parliament
- Decision by Parliament, 1st reading: T7-0383/2014
- Debate in Council: 3276
- Committee report tabled for plenary, 1st reading: A7-0355/2013
- Committee opinion: PE514.880
- Committee opinion: PE513.019
- Committee opinion: PE514.663
- Amendments tabled in committee: PE516.922
- Committee draft report: PE513.309
- Economic and Social Committee: opinion, report: CES1600/2013
- Contribution: COM(2013)0078
- Contribution: COM(2013)0078
- Contribution: COM(2013)0078
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SWD(2013)0033
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SWD(2013)0034
- Legislative proposal published: COM(2013)0078
- Legislative proposal published: EUR-Lex
- Document attached to the procedure: EUR-Lex SWD(2013)0033
- Document attached to the procedure: EUR-Lex SWD(2013)0034
- Economic and Social Committee: opinion, report: CES1600/2013
- Committee draft report: PE513.309
- Amendments tabled in committee: PE516.922
- Committee opinion: PE513.019
- Committee opinion: PE514.663
- Committee opinion: PE514.880
- Commission response to text adopted in plenary: SP(2014)471
- Contribution: COM(2013)0078
- Contribution: COM(2013)0078
- Contribution: COM(2013)0078
Votes
A7-0355/2013 - Christel Schaldemose - Am 13 #
A7-0355/2013 - Christel Schaldemose - Am 16 #
A7-0355/2013 - Christel Schaldemose - Am 18 #
A7-0355/2013 - Christel Schaldemose - Am 19 #
A7-0355/2013 - Christel Schaldemose - Am 48 #
A7-0355/2013 - Christel Schaldemose - Am 53 #
A7-0355/2013 - Christel Schaldemose - Am 60 #
A7-0355/2013 - Christel Schaldemose - Am 94S=96S= #
A7-0355/2013 - Christel Schaldemose - Am 61 #
A7-0355/2013 - Christel Schaldemose - Am 62 #
A7-0355/2013 - Christel Schaldemose - Am 30 #
A7-0355/2013 - Christel Schaldemose - Am 31 #
A7-0355/2013 - Christel Schaldemose - Am 32 #
A7-0355/2013 - Christel Schaldemose - Résolution législative #
Amendments | Dossier |
436 |
2013/0049(COD)
2013/06/27
INTA
55 amendments...
Amendment 10 #
Proposal for a regulation Recital 13 (13) The safety of products should be assessed taking into account all the relevant aspects, in particular their characteristics, composition, authenticity and presentation as well as the categories of consumers who are likely to use the products taking into account their vulnerability, in particular children, the elderly and the disabled.
Amendment 11 #
Proposal for a regulation Recital 13 (13) The safety of products should be assessed taking into account all the relevant aspects, in particular their characteristics, authenticity and presentation as well as the categories of consumers who are likely to use the products taking into account their vulnerability, in particular children, the elderly and the disabled.
Amendment 12 #
Proposal for a regulation Recital 15 a (new) (15a) In the case of products that are not subject to Union harmonisation legislation, EU standards or national legislation on health and safety requirements, economic operators will assess the safety of products according to specific criteria, on which basis they will define the level of risk associated to a product. Market surveillance authorities may assist economic operators in carrying out the safety assessment.
Amendment 13 #
Proposal for a regulation Recital 16 a (new) (16a) 'risk' means a risk that has the potential to affect adversely health and safety of persons in general, health and safety in the work place, consumer protection, the environment and public security as well as other public interests to a degree which goes beyond that considered reasonable and acceptable under the normal or reasonably foreseeable conditions of use of the product concerned, including the duration of the use and, where applicable, its putting into service, installation and maintenance requirements;
Amendment 14 #
Proposal for a regulation Recital 20 (20)
Amendment 15 #
Proposal for a regulation Recital 20 (20) Ensuring product identification and the traceability of products throughout the entire supply chain helps to identify economic operators and to take effective corrective measures against unsafe products, such as targeted recalls and product destruction. Product
Amendment 16 #
Proposal for a regulation Recital 20 a (new) (20a) A simplified, reliable and harmonised EU-wide labelling and certification system is essential in order to help companies and consumers find their way around.
Amendment 17 #
Proposal for a regulation Recital 20 b (new) (20b) The labelling of the origin of products should be based on stringent specifications and criteria.
Amendment 18 #
Proposal for a regulation Recital 21 Amendment 19 #
Proposal for a regulation Recital 21 Amendment 20 #
Proposal for a regulation Recital 21 (21) The indication of origin supplements the basic traceability requirements concerning the name and address of the manufacturer. In particular, the indication of the country of origin may help
Amendment 21 #
Proposal for a regulation Recital 21 (21) Underlines the necessity of product traceability and tracking labels for determining the country of origin of the product and the manufacturer responsible; It is vital to ensure reliable traceability throughout all stages of the life of a product, but to ensure at the same time that this does not lead to increased administrative burdens. The indication of origin supplements the basic traceability requirements concerning the name and address of the manufacturer. In particular, the indication of the country of origin helps to identify the actual place of manufacture in all those cases where the manufacturer cannot be contacted or its given address is different from the actual place of manufacture, to enable consumers to be informed about the sustainability of a product in terms of social, environmental and manufacturing standards as well as about the quality and safety of the product itself. Such information can facilitate the task of market surveillance authorities in tracing the product back to the actual place of manufacture and enable contacts with the authorities of the countries of origin in the framework of bilateral or multilateral
Amendment 22 #
Proposal for a regulation Recital 21 (21) The indication of origin supplements the basic traceability requirements concerning the name and address of the manufacturer. In particular, the indication of the country of origin helps to identify the actual place of manufacture in all those cases where the manufacturer cannot be contacted or its given address is different from the actual place of manufacture. The indication of the origin of the materials that make up the product completes the information for consumers. Such information can facilitate the task of market surveillance authorities in tracing the product back to the actual place of manufacture and enable contacts with the authorities of the countries of origin in the
Amendment 23 #
Proposal for a regulation Recital 21 a (new) (21a) Public information and awareness-raising campaigns should be conducted on the role of the market surveillance authorities, to enable consumers to refer matters to them as needed.
Amendment 24 #
Proposal for a regulation Recital 30 (30) Member States should lay down rules on penalties applicable to infringements of this Regulation and ensure that they are
Amendment 25 #
Proposal for a regulation Article 2 – paragraph 1 – introductory part 1. This Regulation shall apply to products obtained through a manufacturing process placed or made available on the market, including the online market, whether new, used or reconditioned, and which comply with any of the following criteria:
Amendment 26 #
Proposal for a regulation Article 2 – paragraph 3 – point l a (new) Amendment 27 #
Proposal for a regulation Article 4 – paragraph 1 a (new) Amendment 28 #
Proposal for a regulation Article 5 – paragraph 1 – point a a (new) (aa) if it is authentic, meaning that the product or any presentation of the product does not bear a trade mark without the authorization of the trademark owner that is identical or similar to a registered trade mark for this product, thereby misleading consumers as to the true identity of the product;
Amendment 29 #
Proposal for a regulation Article 6 – paragraph 1 – subparagraph 1 – point a a) the characteristics of the product, including its composition, authenticity, packaging, instructions for assembly and, where applicable, for installation and maintenance;
Amendment 30 #
Proposal for a regulation Article 6 – paragraph 1 – subparagraph 1 – point a (a) the characteristics of the product, including its composition, authenticity, packaging, instructions for assembly and, where applicable, for installation and maintenance;
Amendment 31 #
Proposal for a regulation Article 6 – paragraph 2 a (new) 2a. For the purpose of paragraphs 1 and 2, economic operators shall make available to national market surveillance authorities a checklist explaining how the parameters as per paragraphs 1 and 2 have been assessed, and how the possible risk of a product has been estimated on the basis of such checklist. Market surveillance authorities will support economic operators in carrying out the assessment upon request.
Amendment 32 #
Proposal for a regulation Article 7 Amendment 33 #
Proposal for a regulation Article 7 – paragraph 1 Amendment 34 #
Proposal for a regulation Article 7 – paragraph 1 1. Manufacturers and importers
Amendment 35 #
Proposal for a regulation Article 7 – paragraph 1 1. Manufacturers and importers shall ensure that products bear an indication of the country of origin of the product or, where the size or nature of the product does not allow it, that indication is to be provided on the packaging or in a document accompanying the product. Where significant parts of the production process take place in different countries, all these countries of origin shall be listed in order of their share in the value chain.
Amendment 36 #
Proposal for a regulation Article 7 – paragraph 1 1. Manufacturers and importers
Amendment 37 #
Proposal for a regulation Article 7 – paragraph 1 1. Manufacturers
Amendment 38 #
Proposal for a regulation Article 7 – paragraph 1 1. Manufacturers and importers shall ensure that products bear an indication of the country of origin of the product and of the materials composing it, or, where the size or nature of the product
Amendment 39 #
Proposal for a regulation Article 7 – paragraph 1 1. Manufacturers and importers shall ensure that end consumer products bear an indication of the country of origin of the product or
Amendment 40 #
Proposal for a regulation Article 7 – paragraph 1 a (new) Amendment 41 #
Proposal for a regulation Article 7 – paragraph 1 a (new) 1a. The words "made in" together with the name of the country of origin shall indicate the origin of goods. The marking may be made in any official language of the EU, which is easily understandable by the final customers in the Member States in which the goods are to be marketed or in the English language by using the words "made in "and the English name of the country of origin. The marking may not appear in characters other than those of the Latin alphabet for products marketed in countries where the language is written in that alphabet.
Amendment 42 #
Proposal for a regulation Article 7 – paragraph 1 b (new) 1b. Art 7 of the Regulation shall apply to those products which are destined for end consumers excluding fisheries and aquaculture products as defined in Article 1 of Regulation ( EC ) No 104/2000 and foodstuff as defined in Article 2 of Regulation ( EC ) No 178/2002 of the European Parliament and of the Council.
Amendment 43 #
Proposal for a regulation Article 7 – paragraph 2 Amendment 44 #
Proposal for a regulation Article 7 – paragraph 3 Amendment 45 #
Proposal for a regulation Article 7 – paragraph 3 Amendment 46 #
Proposal for a regulation Article 7 – paragraph 3 3. Where the country of origin determined in accordance with paragraph 2 is a Member State of the Union,
Amendment 47 #
Proposal for a regulation Article 7 – paragraph 3 a (new) 3a. Calls the Commission to ensure that the manufacturers should in addition to the "made in" labelling, provide information about the safety of their products to the public authorities. Stresses that, obligations for distributors should be compulsive to check if the manufacturer or importer has labelled the consumer product in proper form before selling or offering it on the EU market.
Amendment 48 #
Proposal for a regulation Article 7 – paragraph 3 a (new) 3a. Goods may be exempted from indication of origin for technical or commercial reasons. Goods may also be exempted from indication of origin when the rules of origin per se determine the country of origin, without providing appropriate information to the consumer, i.e. in those cases where the product is the result of a complex diversified and transnational production chain or when the value added given to the product in the country of final substantial transformation is of inferior significance.
Amendment 49 #
Proposal for a regulation Article 8 – paragraph 3 3. Proportionate to the possible risks of a product as assessed on the basis of Article 6, manufacturers shall, to protect the health and safety of consumers, entrust an independent third body with the task of carrying out conformity checks, carry out sample testing of products made available on the market, investigate complaints and keep a register of complaints, non- conforming products and product recalls, and shall keep distributors informed of any such monitoring.
Amendment 50 #
Proposal for a regulation Article 8 – paragraph 4 – subparagraph 1 – introductory part Proportionate to the possible risks of a product as assessed on the basis of Article 6, manufacturers shall draw up a technical documentation. The technical documentation shall contain, as appropriate:
Amendment 51 #
Proposal for a regulation Article 10 – paragraph 1 1. Before placing a product on the market importers
Amendment 52 #
Proposal for a regulation Article 10 – paragraph 1 a (new) 1a. Since obligations as per Article 8(4) are based on the risk evaluation of a product, which could be based on different criteria and parameters in third countries, it is the responsibility of the importer to ensure that the foreign manufacturer has taken into account the same EU parameters as per Article 6 and which will be reported in the technical documentation it will have provided to the importer.
Amendment 53 #
Proposal for a regulation Article 10 – paragraph 3 a (new) 3a. Importers shall ensure that their products bear a type, batch or serial number or other element allowing the identification of the product which is easily visible and legible for consumers, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the product.
Amendment 54 #
Proposal for a regulation Article 10 – paragraph 4 – subparagraph 1 Importers shall ensure that the product is accompanied by instructions and safety information in
Amendment 55 #
Proposal for a regulation Article 10 – paragraph 6 6. Proportionate to the possible risks presented by a product as assessed on the basis of Article 6, importers shall, to protect the health and safety of persons, carry out sample testing of marketed products, investigate complaints, and keep a register of complaints, of non- conforming products and of product recalls, and shall keep the manufacturer and distributors informed of such monitoring.
Amendment 56 #
Proposal for a regulation Article 10 – paragraph 7 7. Importers who consider or have reason to believe that a product which they have placed on the market is not safe or is otherwise not in conformity with this Regulation shall immediately take the corrective action necessary to bring that product into conformity, to withdraw it or recall it
Amendment 57 #
Proposal for a regulation Article 10 – paragraph 8 8. Importers shall keep, for a period of ten years after the product has been placed on the market, the technical documentation and make it available to the market surveillance authorities, upon request, as well as any economic operator to whom he distributes his products, with evidence supporting the existence of essential differences between its models.
Amendment 58 #
Proposal for a regulation Article 11 – paragraph 5 5. Distributors who consider or have reason to believe that a product which they have made available on the Union or on-line market is not safe or is not in conformity with Article 8(6), (7) and (8) and Article 10(3) and (4), as applicable, shall make sure that the corrective action necessary to bring that product into conformity is taken, to withdraw it or recall it
Amendment 59 #
Proposal for a regulation Article 13 Amendment 60 #
Proposal for a regulation Article 15 – paragraph 1 1. For
Amendment 61 #
Proposal for a regulation Article 15 – paragraph 2 2. The system of traceability shall consist of the collection and storage of data by electronic means enabling the identification of the product and of the economic operators involved in its supply chain, including EU and foreign manufacturers, as well as of the placement of a data carrier on the product, its packaging or accompanying documents enabling access to that data. The system of traceability shall apply to both domestically produced and imported products.
Amendment 62 #
Proposal for a regulation Article 15 – paragraph 3 – point a (a) determining the products, categories or groups of products susceptible to bear a
Amendment 63 #
Proposal for a regulation Article 18 – paragraph 1 1. The Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, harmonised, proportionate and dissuasive. Member States shall notify those provisions to the Commission by [insert date - 3 months prior to the date of application of this Regulation] and shall notify it without delay of any subsequent amendment affecting them.
Amendment 64 #
Proposal for a regulation Article 18 – paragraph 1 1. The Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and
source: PE-514.717
2013/08/29
JURI
20 amendments...
Amendment 25 #
Proposal for a regulation Recital 13 (13) The safety of products should be assessed taking into account all the relevant aspects, in particular their characteristics, composition and presentation as well as the categories of consumers who are likely to use the products taking into account their vulnerability, and in particular children, the elderly and the disabled.
Amendment 26 #
Proposal for a regulation Recital 13 (13) The safety of products should be assessed taking into account all the relevant aspects, in particular their characteristics, authenticity and presentation as well as the categories of consumers who are likely to use the products taking into account their vulnerability, in particular children, the elderly and the disabled.
Amendment 27 #
Proposal for a regulation Recital 20 (20) Ensuring product identification and the traceability of products throughout the entire supply chain helps to identify economic operators and to take effective corrective measures against unsafe products, such as targeted recalls and product destruction. Product identification and traceability thus ensure that consumers and economic operators obtain accurate information regarding unsafe products which enhances confidence in the market and avoids unnecessary disruption of trade. Products should therefore bear information allowing their identification and the identification of the manufacturer and, if applicable, of the importer. Manufacturers should also establish technical documentations regarding their products for which they may choose the most appropriate and cost-
Amendment 28 #
Proposal for a regulation Recital 21 (21) The indication of origin supplements the basic traceability requirements concerning the name and address of the manufacturer. In particular, the indication of the country of origin helps to identify the actual place of manufacture in all those cases where the manufacturer cannot be contacted or its given address is different from the actual place of manufacture. Modern business processes regarding the purchasing and processing of materials are such that the indication of the country of origin of the finished product is insufficient to provide consumers with full and trustworthy information on the true origin of that product. Indicating the country of origin of the materials used in the product guarantees consumers the right to make purchasing choices in full knowledge of the facts. Such information can facilitate the task of market surveillance authorities in tracing the product back to the actual place of manufacture and enable contacts with the authorities of the countries of origin in the framework of bilateral or multilateral cooperation on consumer product safety for appropriate follow up actions.
Amendment 29 #
Proposal for a regulation Article 3 – paragraph 1 – point 1 (1) ‘safe product’ means any authentic product which, under normal or reasonably foreseeable conditions of use of the product concerned, including the duration of use and, where applicable, its putting into service, installation and maintenance requirements, does not present any risk or only the minimum risks compatible with the product's use, considered acceptable and consistent with a high level of protection of health and safety of persons;
Amendment 30 #
Proposal for a regulation Article 4 – paragraph 1 Economic operators shall
Amendment 31 #
Proposal for a regulation Article 5 – paragraph 1 – point a a (new) (aa) when it is authentic – i.e. has been manufactured in compliance with the regulatory requirements, bears the relevant identifying marks and has been placed on the EU market by the intellectual property rights holder or with his consent;
Amendment 32 #
Proposal for a regulation Article 6 – paragraph 1 – subparagraph 1 – point a (a) the characteristics of the product, including its authenticity, composition, packaging, instructions for assembly and, where applicable, for installation and maintenance;
Amendment 33 #
Proposal for a regulation Article 6 – paragraph 1 – subparagraph 1 – point d (d) the categories of consumers at risk when using the product, in particular vulnerable consumers, such as children, older people and the disabled;
Amendment 34 #
Proposal for a regulation Article 6 – paragraph 2 a (new) 2a. Safety standards and rules commonly applicable to similar products.
Amendment 35 #
Proposal for a regulation Article 7 – paragraph 1 1. Manufacturers and importers shall ensure that products bear an indication of the country of origin of the product and of the materials used in it or, where the size or nature of the product does not allow it, that indication is to be provided on the packaging or in a document accompanying the product.
Amendment 36 #
Proposal for a regulation Article 11 – paragraph 2 2. Before making a product available on the market distributors shall verify that the
Amendment 37 #
Proposal for a regulation Article 13 – paragraph 1 – point c Amendment 38 #
Proposal for a regulation Article 13 – paragraph 3 Amendment 39 #
Proposal for a regulation Article 13 – paragraph 3 3. The Commission
Amendment 40 #
Proposal for a regulation Article 15 – paragraph 3 Amendment 41 #
Proposal for a regulation Article 15 – paragraph 3 – introductory part 3. The Commission shall
Amendment 42 #
Proposal for a regulation Article 15 – paragraph 3 – point a (a) determin
Amendment 43 #
Proposal for a regulation Article 15 – paragraph 3 – point b (b) specify
Amendment 44 #
Proposal for a regulation Article 20 source: PE-516.881
2013/09/06
ITRE
83 amendments...
Amendment 100 #
Proposal for a regulation Article 16 – paragraph 1 – subparagraph 1 The Commission may request one or several European standardisation organisations to draft or identify a European standard, which aims at ensuring that products that conform to such standard
Amendment 101 #
Proposal for a regulation Article 16 – paragraph 1 – subparagraph 2 The Commission shall adopt the request referred to in the first subparagraph by a
Amendment 102 #
Proposal for a regulation Article 18 Amendment 103 #
Proposal for a regulation Article 18 – paragraph 2 Amendment 104 #
Proposal for a regulation Article 20 – paragraph 2 2. The power to adopt delegated acts referred to in Articles 13(3) and 15(3) shall be conferred on the Commission for a
Amendment 22 #
Proposal for a regulation Citation 1 Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 26 and 114 thereof,
Amendment 23 #
Proposal for a regulation Recital 6 a (new) (6a) Products which are designed for professionals but have subsequently migrated to the consumer market and sold to ordinary consumers should be subject to this Regulation.
Amendment 24 #
Proposal for a regulation Recital 8 (8) In respect of the consumer products subject to this Regulation the scope of its application
Amendment 25 #
Proposal for a regulation Recital 10 (10) The scope of this Regulation should not be limited to any selling technique of consumer products, and thus also cover distance selling such as online sales.
Amendment 26 #
Proposal for a regulation Recital 11 (11) This Regulation should apply to second hand products that re-enter the supply chain in the course of a commercial activity
Amendment 27 #
Proposal for a regulation Recital 13 (13) The safety of products should be assessed taking into account all the relevant aspects, in particular their characteristics and presentation as well as the categories of consumers who are likely to use the products under reasonably foreseeable conditions, taking into account their vulnerability, in particular children, the elderly and the disabled.
Amendment 28 #
Proposal for a regulation Recital 13 (13) The safety of products should be assessed taking into account all the relevant aspects, in particular their characteristics, composition and presentation as well as the categories of consumers who are likely to use the products taking into account their vulnerability, in particular children, the elderly and the disabled. The assessment shall take into account the precautionary principle.
Amendment 29 #
Proposal for a regulation Recital 13 (13) The safety of products should be assessed taking into account all the relevant aspects, in particular their characteristics
Amendment 30 #
Proposal for a regulation Recital 14 (14) To avoid overlapping safety requirements and conflicts with other Union legislation, a product which
Amendment 31 #
Proposal for a regulation Recital 20 (20) Ensuring product identification and the traceability of products throughout the entire supply chain helps to identify economic operators and to take effective corrective measures against unsafe products, such as targeted recalls. Product identification and traceability
Amendment 32 #
Proposal for a regulation Recital 20 (20) Ensuring product identification and the traceability of products throughout the entire supply chain helps to identify economic operators and to take effective corrective measures against unsafe products, such as targeted recalls. Product identification and traceability thus ensure that consumers and economic operators obtain accurate information regarding unsafe products which enhances confidence in the market and avoids unnecessary disruption of trade. Products should therefore bear information allowing their identification and the identification of the manufacturer
Amendment 33 #
Proposal for a regulation Recital 21 Amendment 34 #
Proposal for a regulation Recital 21 Amendment 35 #
Proposal for a regulation Recital 21 Amendment 36 #
Proposal for a regulation Recital 24 (24) The procedures to request European standards in support of this Regulation, and
Amendment 37 #
Proposal for a regulation Recital 27 (27) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards the exemption to the obligation to inform market surveillance authorities about products presenting a risk, as regards the type of data carrier and its placement on the product for the purposes of the traceability system
Amendment 38 #
Proposal for a regulation Article 2 – paragraph 1 – point b (b) which are likely, under reasonably foreseeable conditions, to be used by consumers even if, when placed on the market, they were not intended for
Amendment 39 #
Proposal for a regulation Article 2 – paragraph 1 – point c (c)
Amendment 40 #
Proposal for a regulation Article 2 – paragraph 2 2. This Regulation shall not apply to products to be repaired or reconditioned prior to being used where those products are made available on the market as such. This regulation shall not apply to private individuals' transactions.
Amendment 41 #
Proposal for a regulation Article 2 – paragraph 4 4.
Amendment 42 #
Proposal for a regulation Article 2 – paragraph 4 4.
Amendment 43 #
Proposal for a regulation Article 3 – paragraph 1 – point 1 (1) ‘safe product’ means any product which, under normal or reasonably foreseeable conditions of use of the product concerned, including the duration of use and, where applicable, its putting into service, installation
Amendment 44 #
Proposal for a regulation Article 3 – paragraph 1 – point 7 (7) ‘distributor’ means any natural or legal accountable person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market; it does not include private individuals transactions, acting on a non- business capacity;
Amendment 45 #
Proposal for a regulation Article 4 Economic operators shall place or make available on the
Amendment 46 #
Proposal for a regulation Article 5 – title Presumption of
Amendment 47 #
Proposal for a regulation Article 5 – paragraph 1 – point a Amendment 48 #
Proposal for a regulation Article 5 – paragraph 1 – point b (b)
Amendment 49 #
Proposal for a regulation Article 5 – paragraph 1 – point c (c) in the absence of requirements laid down in or pursuant to
Amendment 50 #
Proposal for a regulation Article 6 – paragraph 1 Amendment 51 #
Proposal for a regulation Article 6 – paragraph 1 – point a (a) the characteristics of the product, including its composition, packaging, instructions for assembly and disassembly, where applicable, for installation and maintenance;
Amendment 52 #
Proposal for a regulation Article 6 – paragraph 1 –point d (d) the categories of consumers at risk when using the product, in particular vulnerable consumers
Amendment 53 #
Proposal for a regulation Article 6 – paragraph 1 a (new) Amendment 54 #
Proposal for a regulation Article 6 – paragraph 2 Amendment 55 #
Proposal for a regulation Article 6 – paragraph 2 – point a Amendment 56 #
Proposal for a regulation Article 6 – paragraph 2 – point h Amendment 57 #
Proposal for a regulation Article 6 – paragraph 2 – point h a (new) Amendment 58 #
Proposal for a regulation Article 6 – paragraph 2 – point h a (new) (ha) the precautionary principle.
Amendment 59 #
Proposal for a regulation Article 6 – paragraph 2 a (new) Amendment 60 #
Proposal for a regulation Article 7 Amendment 61 #
Proposal for a regulation Article 7 Amendment 62 #
Proposal for a regulation Article 7 Amendment 63 #
Proposal for a regulation Article 7 – paragraph 1 1. Manufacturers and importers
Amendment 64 #
Proposal for a regulation Article 8 – paragraph 4 – point c a (new) (ca) where the manufacturer does not place the product on the market, name, registered trade name or registered trade mark of the manufacturer and the address at which he can be contacted.
Amendment 65 #
Proposal for a regulation Article 8 – paragraph 5 5. Manufacturers shall
Amendment 66 #
Proposal for a regulation Article 8 – paragraph 5 5. Manufacturers shall keep, for a period of ten years after the product has been placed on the market, the technical documentation and make it available to the market surveillance authorities, upon a reasoned request.
Amendment 67 #
Proposal for a regulation Article 8 – paragraph 5 5. Manufacturers shall keep, for a period of
Amendment 68 #
Proposal for a regulation Article 8 – paragraph 7 7.
Amendment 69 #
Proposal for a regulation Article 8 – paragraph 8 – subparagraph 1 Manufacturers shall ensure that their product is accompanied by instructions and safety information in a language which can be easily understood by consumers, as determined by the Member State in which the product is made available, except where the product can be used safely and as intended by the manufacturer without such instructions and safety information. The safety information shall enable consumers to assess the risks inherent in a product throughout the normal or reasonably foreseeable period of its use, where such risks are not immediately obvious without adequate warning;
Amendment 70 #
Proposal for a regulation Article 8 – paragraph 8 – subparagraph 1 Manufacturers shall ensure that their product is accompanied by instructions and safety information in a language which can be easily understood by consumers, as determined by the Member State in which the product is made available
Amendment 71 #
Proposal for a regulation Article 8 – paragraph 8 – subparagraph 1 Manufacturers shall ensure that their product is accompanied by instructions and safety information in a language or visual format which can be easily understood by consumers, as determined by the Member State in which the product is made available, except where the product can be used safely and as intended by the manufacturer without such instructions and safety information.
Amendment 72 #
Proposal for a regulation Article 8 – paragraph 9 9. Manufacturers who consider or have reason to believe that a product which they have placed on the market is not safe or is otherwise not in conformity with this Regulation shall immediately take the corrective action necessary to bring that product into conformity, to withdraw it or recall it,
Amendment 73 #
Proposal for a regulation Article 9 – paragraph 2 – point a (a) further to a reasoned request from a market surveillance authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a product;
Amendment 74 #
Proposal for a regulation Article 10 – paragraph 1 1. Before placing a product on the market importers shall ensure that the product is compliant with the general safety requirement laid down in Article 4 and that the manufacturer has complied with the requirements set out in Article 8(4)
Amendment 75 #
Proposal for a regulation Article 10 – paragraph 3 3. Importers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product or, where that is not possible, on its packaging or in a document accompanying the product or on a website clearly indicated on the product or its packaging or accompanying documents. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer.
Amendment 76 #
Proposal for a regulation Article 10 – paragraph 4 – subparagraph 1 Importers shall ensure that the product is accompanied by instructions and safety information in a language which can be easily understood by consumers, as determined by the Member State in which the product is made available
Amendment 77 #
Proposal for a regulation Article 10 – paragraph 4 – subparagraph 1 Importers shall ensure that the product is accompanied by instructions and safety information in a language or visual format which can be easily understood by consumers, as determined by the Member State in which the product is made available, except where the product can be used safely and as intended by the manufacturer without such instructions and safety information.
Amendment 78 #
Proposal for a regulation Article 10 – paragraph 7 7. Importers who consider or have reason to believe that a product which they have placed on the market is not safe or is otherwise not in conformity with this
Amendment 79 #
Proposal for a regulation Article 10 – paragraph 8 8. Importers shall
Amendment 80 #
Proposal for a regulation Article 10 – paragraph 8 8. Importers shall keep, for a period of
Amendment 81 #
Proposal for a regulation Article 11 – paragraph 2 2. Before making a product available on the market distributors shall verify that the
Amendment 82 #
Proposal for a regulation Article 11 – paragraph 2 2. Before making a product available on the market distributors shall verify that the
Amendment 83 #
Proposal for a regulation Article 11 – paragraph 5 5. Distributors who consider or have reason to believe that a product which they have made available on the market is not safe or is not in conformity with Article 8(6), (7) and (8) and Article 10(3) and (4), as applicable, shall make sure that the corrective action necessary to bring that product into conformity is taken, to
Amendment 84 #
Proposal for a regulation Article 11 – paragraph 5 a (new) (5a) Distributors shall only make available on the market products that come with safety instructions and information in all the official languages of the country in which they are placing a product on the market, under the conditions set by the Member State concerned.
Amendment 85 #
Proposal for a regulation Article 13 – paragraph 1 – point a Amendment 86 #
Proposal for a regulation Article 13 – paragraph 1 – point b (b) the manufacturer, importer or distributor can demonstrate that the risk has been
Amendment 87 #
Proposal for a regulation Article 13 – paragraph 1 – point c Amendment 88 #
Proposal for a regulation Article 13 – paragraph 3 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 20 determining the products, categories or groups of products for which, due to their low level of risk, the information referred to in Article 8(7) and Article 10(3)
Amendment 89 #
Proposal for a regulation Article 13 – paragraph 3 a (new) (3a) The Commission shall be empowered to adopt delegated acts in accordance with Article 20 determining the requirements of Article 8, Article 10, Article 11 and Article 14 of this regulation from which distributors of second-hand goods may be exempted, based on the low level of risk involved or the excessive burden they create on the economic activity of those smaller-scale operators.
Amendment 90 #
Proposal for a regulation Article 14 – paragraph 2 2. Economic operators shall be able to present the information referred to in the first paragraph for a period of
Amendment 91 #
Proposal for a regulation Article 14 – paragraph 2 2. Economic operators shall be able to present the information referred to in the first paragraph for a period of 1
Amendment 92 #
Proposal for a regulation Article 14 – paragraph 2 2. Economic operators shall be able to present the information referred to in the first paragraph for a period
Amendment 93 #
Proposal for a regulation Article 14 – paragraph 2 a (new) (2a) Where economic operators identify the information referred to in the first paragraph, the market surveillance authorities shall treat this information as confidential.
Amendment 94 #
Proposal for a regulation Article 15 Amendment 95 #
Proposal for a regulation Article 15 – title Traceability of products susceptible to bear a serious risk
Amendment 96 #
Proposal for a regulation Article 15 – paragraph 1 1. For certain products, categories or groups of products which, due to their specific characteristics or specific conditions of distribution or usage, susceptible to bear a serious risk to health and safety of persons, and after consulting relevant stakeholders, as appropriate, the Commission may require economic operators who place and make available those products on the market to establish or adhere to a system of traceability.
Amendment 97 #
Proposal for a regulation Article 15 – paragraph 1 1. For certain products, categories or groups of products which, due to their specific characteristics or specific conditions of distribution or usage, susceptible to bear a serious risk to health and safety of persons, the Commission may require economic operators who place and make available those products on the market to establish or adhere to a system of traceability for the manufacturer.
Amendment 98 #
Proposal for a regulation Article 15 – paragraph 2 2. The system of traceability shall consist of the collection and storage of data by electronic means enabling the identification of
Amendment 99 #
Proposal for a regulation Article 15 – paragraph 3 – point b (b) specifying the data which economic operators shall collect and store by means of the traceability system referred to in paragraph 2 and are necessary for ensuring product safety.
source: PE-516.836
2013/09/16
IMCO
278 amendments...
Amendment 100 #
Proposal for a regulation Recital 21 Amendment 101 #
Proposal for a regulation Recital 21 Amendment 102 #
Proposal for a regulation Recital 21 Amendment 103 #
Proposal for a regulation Recital 21 (21) Ensuring the traceability of a product throughout its life cycle and the use of tracking labels to determine the country of origin and the manufacturer responsible are very important and necessary. At the same time, the measures concerned should not result in a disproportionate administrative burden. The indication of origin supplements the basic traceability requirements concerning the name and address of the manufacturer. In particular, the indication of the country of origin helps to identify the actual place of manufacture in all those cases where the manufacturer cannot be contacted or its given address is different from the actual place of manufacture. At the same time the indication of origin can help consumers to obtain information about the sustainability of a product with reference to social and ecological standards, as well as about general safety and quality. Such information can facilitate the task of market surveillance authorities in tracing the product back to the actual place of manufacture and enable contacts with the authorities of the countries of origin in the
Amendment 104 #
Proposal for a regulation Recital 21 (21) The indication of origin supplements the basic traceability requirements concerning the name and address of the manufacturer. In particular, the indication of the country of origin helps to identify the actual place of manufacture in all those cases where the manufacturer cannot be contacted or its given address is different from the actual place of manufacture. Modern business processes as regards the purchasing and processing of materials are such that it is not sufficient to indicate the country of origin of the finished product in order to ensure that consumers are fully and accurately informed regarding its true provenance. Information regarding the country of origin of the constituent materials ensures that the right of consumers to make informed purchasing choices is respected. Such information can facilitate the task of market surveillance authorities in tracing the product back to the actual place of manufacture and enable contacts with the
Amendment 105 #
Proposal for a regulation Recital 21 a (new) Amendment 106 #
Proposal for a regulation Recital 24 (24) The procedures to request European standards in support of this Regulation, and on formal objections against them, should be laid down in this Regulation and be aligned with Regulation (EU) No 1025/2012. To ensure overall consistency in European standardisation issues, requests for European standards, or objections to a European standard, should therefore be brought before the committee set up by that Regulation, after appropriate consultation of experts of the Member States in the field of consumer product safety
Amendment 107 #
Proposal for a regulation Recital 27 (27) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards the exemption to the obligation to inform market surveillance authorities about products presenting a risk, as regards the type of data carrier and its placement on the product for the purposes of the traceability system
Amendment 108 #
Proposal for a regulation Recital 29 Amendment 109 #
Proposal for a regulation Recital 29 Amendment 110 #
Proposal for a regulation Recital 29 (29) In order to maintain a high level of health and safety of consumers, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of products for which the name and address of the manufacturer and of the importer does not need to be indicated on the product itself due to the low level of risk related to such products, and in respect of the identification and traceability of products bearing a potential serious risk to health and safety. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, particularly involving consumer protection organisations. The Commission,
Amendment 112 #
Proposal for a regulation Article 1 The objective of this Regulation is to ensure the proper functioning of the internal market whilst maintaining a high level of health, safety and consumer protection. This Regulation lays down rules on the safety of consumer products placed or made available on the Union market.
Amendment 113 #
Proposal for a regulation Article 1 This Regulation lays down rules on the safety of consumer products placed or made available on the Union market and its main aim is to ensure that products available on the market are safe for consumers.
Amendment 114 #
Proposal for a regulation Article 2 – paragraph 1 – point b (b) which are likely, under reasonably foreseeable conditions, to be used by consumers even if not directly intended for them; products are not likely to be used by consumers if they are intended, under reasonably foreseeable conditions, for the exclusive use by professionals and explicitly labelled and presented as such;
Amendment 115 #
Proposal for a regulation Article 2 – paragraph 1 – point b (b) which are likely, under reasonably foreseeable conditions, to be used by consumers even if, when placed on the market, they were not intended for
Amendment 116 #
Proposal for a regulation Article 2 – paragraph 1 – point c (c)
Amendment 117 #
Proposal for a regulation Article 2 – paragraph 2 2. This Regulation shall not apply to products to be repaired or reconditioned prior to being used where those products are made available on the market as such nor to second hand products originally placed on the market before the entry into force of this Regulation.
Amendment 118 #
Proposal for a regulation Article 2 – paragraph 3 – point a (a) medicinal products and medical devices for human or veterinary use;
Amendment 119 #
Proposal for a regulation Article 2 – paragraph 3 – point c Amendment 120 #
Proposal for a regulation Article 2 – paragraph 3 – point d a (new) (da) medicinal devices as referred to in Directive 93/42/EEC concerning medicinal devices, Directive 90/385/EEC concerning active implantable medical devices and Directive 98/79/EC concerning in vitro diagnostic medical devices;
Amendment 121 #
Proposal for a regulation Article 2 – paragraph 3 – point j a (new) (ja) construction products as referred to in Regulation (EU) No 305/2011 of 9 March 2011;
Amendment 122 #
Proposal for a regulation Article 2 – paragraph 3 – point h Amendment 123 #
Proposal for a regulation Article 2 – paragraph 3 – point i a (new) (ia) construction products on the basis of the Regulation (EU) No. 305/2011 of March 2011.
Amendment 124 #
Proposal for a regulation Article 2 – paragraph 4 4.
Amendment 125 #
Proposal for a regulation Article 2 – paragraph 4 4. Chapters II to IV of this Regulation shall
Amendment 126 #
Proposal for a regulation Article 2 – paragraph 4 4.
Amendment 127 #
Proposal for a regulation Article 2 – paragraph 4 4. Chapter
Amendment 128 #
Proposal for a regulation Article 3 – point 1 (1) ‘safe product’ means any product which, under normal or reasonably foreseeable conditions of use of the product concerned, including the duration of use and, where applicable, its putting into service, installation
Amendment 129 #
Proposal for a regulation Article 3 – point 1 (1) ‘safe product’ means any product which is genuine and which, under normal or reasonably foreseeable conditions of use of the product concerned, including the duration of use and, where applicable, its putting into service, installation and maintenance requirements, does not present any risk or only the minimum risks compatible with the product's use, considered acceptable and consistent with a high level of protection of health and safety of persons;
Amendment 130 #
Proposal for a regulation Article 3 – point 1 (1) ‘safe product’ means any authentic product which, under normal or reasonably
Amendment 131 #
Proposal for a regulation Article 3 – point 1 (1)
Amendment 132 #
Proposal for a regulation Article 3 – point 1 a (new) (1a) 'product model' means products that are considered to be distinct as presenting identical or similar essential characteristics, with differences, if any, having no impact on their safety level unless otherwise proven by the manufacturer or the importer.
Amendment 133 #
Proposal for a regulation Article 3 – point 1 a (new) (1a) 'product model' means products that are considered to be distinct although presenting identical or similar essential characteristics, with differences which do not impact their safety level unless otherwise proven by the manufacturer or the importer;
Amendment 134 #
Proposal for a regulation Article 3 – point 1 a (new) (1a) 'dangerous product' means any product which is not a safe product within the meaning of point 1;
Amendment 135 #
Proposal for a regulation Article 3 – point 1 a (new) (1a) ‘product model’ means products regarded as distinctive in so far as their essential characteristics are identical or similar and where any differences between them have no impact on their level of safety unless otherwise shown by the manufacturer or importer;
Amendment 136 #
Proposal for a regulation Article 3 – paragraph 1 – point 1 b (new) (1b) ´product model' means products that are considered to be distinct as presenting identical or similar essential characteristics, with differences, if any, having no impact on their safety level unless otherwise proven by the manufacturer or the importer.
Amendment 137 #
Proposal for a regulation Article 3 – paragraph 1 – point 2 (2) ‘making available on the market’ means any supply of a product for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge; it also includes all forms of distance selling;
Amendment 138 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 (3) ‘placing on the market’ means the first making available of a product on the Union market; it also includes all forms of distance selling;
Amendment 139 #
Proposal for a regulation Article 3 – paragraph 1 – point 13 a (new) (13a) 'product presenting a serious risk' means a product presenting a risk requiring rapid intervention and follow- up, including cases where the effects may not be immediate, any product that does not meet an essential requirement defined in the harmonisation legislation, as well as any product that does not meet the general safety requirement as defined in the mandate given be the Commission to the standardisation organisation shall be considered as presenting a serious risk;
Amendment 140 #
Proposal for a regulation Article 3 – paragraph 1 – point 13 b (new) (13b) 'product models' means products that are considered distinct by presenting identical or similar essential characteristics. Differences, if any, should have no impact on their safety levels
Amendment 141 #
Proposal for a regulation Article 3 – paragraph 1 – point 16 (16) ‘Union harmonisation legislation’ means any Union legislation harmonising the conditions for the marketing of products. It defines the essential requirements which products must comply with in order to be placed on the European market.;
Amendment 142 #
Proposal for a regulation Article 3 – paragraph 1 – point 17 a (new) (17a) 'Vulnerable consumers' are persons who have difficulties in accessing and comprehending relevant consumer information or because of their mental, physical or psychological disability or their age are more exposed to safety risk, and therefore need special protection.
Amendment 143 #
Proposal for a regulation Article 5 – introductory part For the purpose of this Regulation, a product shall be presumed to be
Amendment 144 #
Proposal for a regulation Article 5 – point a Amendment 145 #
Proposal for a regulation Article 5 – point a (a) as regards the risks covered by
Amendment 146 #
Proposal for a regulation Article 5 – point b (b)
Amendment 147 #
Proposal for a regulation Article 5 – point b (b) in the absence of requirements laid down in or pursuant to Union harmonisation legislation referred to in point (a), as regards the risks covered by European standards, if it conforms to relevant European standards or parts thereof, the references of which have been published in the Official Journal of the European Union in accordance with Articles 16 and 17, and where appropriate, if it meets the additional health and safety requirements contained in the legislation of the Member State where the product is made available on the market;
Amendment 148 #
Proposal for a regulation Article 5 – point c (c) in the absence of requirements laid down in or pursuant to
Amendment 149 #
Proposal for a regulation Article 5 – point c (c) in the absence of requirements laid down in or pursuant to Union harmonisation legislation referred to in
Amendment 150 #
Proposal for a regulation Article 5 – paragraph 1 a (new) An operator who places on the market a product that is not covered by the cases laid down under the paragraph 1 shall provide, upon request, the market surveillance authorities as well as any economic operator to whom the products are distributed, with evidence of the product's safety. In case of non- compliance with this requirement, the product shall be withdrawn from the market.
Amendment 151 #
Proposal for a regulation Article 5 - paragraph 1 a (new) The presumption of safety does not exonerate the market surveillance authorities from carrying out actions pursuant to the Regulation on market surveillance in cases where new evidence arises of risks posed by a product, even though it meets or complies with the requirements.
Amendment 152 #
Proposal for a regulation Article 6 a (new) Article 6a When assessing the safety of a product, the precautionary principle shall in all cases be taken into account.
Amendment 153 #
Proposal for a regulation Article 6 – paragraph 1 Amendment 154 #
Proposal for a regulation Article 6 – paragraph 1 a (new) Amendment 155 #
Proposal for a regulation Article 6 – paragraph 1 – subparagraph 1 – introductory part In the absence of Union harmonisation legislation, European standards or health and safety requirements laid down in the law of the Member State where the product is made available on the market as referred to in points (a), (b) and (c) of Article 5,
Amendment 156 #
Proposal for a regulation Article 6 – paragraph 1 – subparagraph 1 – introductory part In order to assess whether a
Amendment 157 #
Proposal for a regulation Article 6 – paragraph 1 – subparagraph 1 a (new) These criteria should be taken into account by all economic operators during the whole production and value chain.
Amendment 158 #
Proposal for a regulation Article 6 – paragraph 1 – subparagraph 1 – point a (a) the characteristics of the product, including its authenticity, composition, packaging, instructions for assembly and, where applicable, for installation and maintenance;
Amendment 159 #
Proposal for a regulation Article 6 – paragraph 1 – subparagraph 1 – point c (c) the presentation of the product, the labelling, any warnings and instructions for its use and disposal and any other indication or information regarding the product, which may also take the form of illustrations or pictograms alone;
Amendment 160 #
Proposal for a regulation Article 6 – paragraph 1 – subparagraph 1 – point c (c) the presentation of the product, the labelling, any warnings and instructions for its use and disposal and any other indication or information regarding the product, which may also take the form of illustrations or pictograms alone;
Amendment 161 #
Proposal for a regulation Article 6 – paragraph 1 – subparagraph 1 – point d (d) the categories of consumers at risk when using the product, in particular vulnerable consumers
Amendment 162 #
Proposal for a regulation Article 6 – paragraph 1 – subparagraph 1 – point d (d) the categories of consumers at risk when using the product
Amendment 163 #
Proposal for a regulation Article 6 – paragraph 1 – subparagraph 1 – point d (d) the categories of consumers at risk when using the product, in particular vulnerable consumers
Amendment 164 #
Proposal for a regulation Article 6 – paragraph 1 – subparagraph 1 – point d (d) the c
Amendment 165 #
Proposal for a regulation Article 6 – paragraph 1 – subparagraph 1 – point e (e) the appearance of the product and in particular where a product
Amendment 166 #
Proposal for a regulation Article 6 – paragraph 1 – subparagraph 1 – point e (e) the appearance of the product, its characteristics and packaging, and in particular where a product, although not foodstuff, resembles foodstuff and is likely to be confused with foodstuff due to its form, odour, colour, appearance, packaging, labelling, volume, size or other characteristics; especially in case of a product which may attract children to using it in a way that poses a risk to their health and safety.
Amendment 167 #
Proposal for a regulation Article 6 – paragraph 1 – subparagraph 1 – point e (e) the appearance of the product and in particular where a product, although not foodstuff, resembles foodstuff and is likely to be confused with foodstuff due to its form, odour, colour, appearance, packaging, labelling, volume, size or other characteristics, or where a product is attractive to children because of its characteristics: form, decoration, odour,, sound, movement, etc.
Amendment 168 #
Proposal for a regulation Article 6 – paragraph 1 – subparagraph 2 The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk shall not constitute sufficient grounds for considering a product not to be safe.
Amendment 169 #
Proposal for a regulation Article 6 – paragraph 2 Amendment 170 #
Proposal for a regulation Article 6 – paragraph 2 a (new) Amendment 171 #
Proposal for a regulation Article 6 – paragraph 2 – point a Amendment 172 #
Proposal for a regulation Article 6 – paragraph 2 – point a Amendment 173 #
Proposal for a regulation Article 6 – paragraph 2 – point a a (new) (aa) the requirements imposed pursuant to Article 16(1) in connection with a standardisation request;
Amendment 174 #
Proposal for a regulation Article 6 – paragraph 2 – point a a (new) (aa) the precautionary principle;
Amendment 175 #
Proposal for a regulation Article 6 – paragraph 2 – point b a (new) (ba) the essential requirements contained in the standardisation mandates in accordance with Article 16 of this Regulation;
Amendment 176 #
Proposal for a regulation Article 6 – paragraph 2 – point c a (new) (ca) standards of other Member States
Amendment 177 #
Proposal for a regulation Article 6 – paragraph 2 – point c b (new) (cb) basic requirements published by the Commission in order to comply with the provisions of Article 4.1(a) of the GPSD
Amendment 178 #
Proposal for a regulation Article 6 – paragraph 2 – point h Amendment 179 #
Proposal for a regulation Article 6 – paragraph 2 – point h Amendment 180 #
Proposal for a regulation Article 6 – paragraph 2 – point h a (new) (ha) Union legislation in regards to alternatives to animal testing used for regulatory purposes as outlined in Regulation (EU) No. 1907/2006, 1223/2009 and Directive No. 2010/63/EU.
Amendment 181 #
Proposal for a regulation Article 6 – paragraph 2 – point h a (new) Amendment 182 #
Proposal for a regulation Article 6 a (new) Article 6 a CE + marking The CE+ marking shall be affixed only by the manufacturer or his authorised representative. The CE+ marking shall be affixed only to consumer products covered by this regulation, and shall not be affixed to any other product. The CE+ marking shall be affixed after testing on representative samples of the products put up for sale pick randomly under the control of a judicial officer, an authority or any other qualified person designated by each Member State. The CE+ marking shall be the only marking which attests that the product has been tasted and found to be a safe product.
Amendment 183 #
Proposal for a regulation Article 6 a (new) Article 6a CE + marking 1. The CE+ marking shall be affixed only by the manufacturer or his authorised representative. 2. The CE+ marking shall be affixed only to consumer products covered by this Regulation, and shall not be affixed to any other product. 3. By affixing or having affixed the CE+ marking, the manufacturer indicates that the product has been tested and found compliant with the safety requirement in this Regulation by an accredited body compent to assess the safety of the specific product. The CE+ marking shall be affixed after testing on representative samples of the products put up for sale pick randomly under the control of a judicial officer, an authority or any other qualified person designated by each Member State. 4. The CE+ marking shall be the only marking which attests that the product has been tested and found to be a safe product. 5. The affixing to a product of markings, signs or inscriptions which are likely to mislead third parties regarding the meaning or form of the CE+ marking shall be prohibited. Any other marking may be affixed to the product provided that the visibility, legibility and meaning of the CE+ marking is not thereby impaired. 6. Member States shall ensure the correct implementation of the regime governing the CE+ marking and take appropriate action in the event of improper use of the marking. Member States shall also provide for penalties for infringements, which may include criminal sanctions for serious infringements. Those penalties shall be proportionate to the seriousness of the offence and constitute an effective deterrent against improper use.
Amendment 184 #
Proposal for a regulation Article 7 Amendment 185 #
Proposal for a regulation Article 7 Amendment 186 #
Proposal for a regulation Article 7 Amendment 187 #
Proposal for a regulation Article 7 Amendment 188 #
Proposal for a regulation Article 7 Amendment 189 #
Proposal for a regulation Article 7 Amendment 190 #
Proposal for a regulation Article 7 Amendment 191 #
Proposal for a regulation Article 7 – paragraph 1 1. Manufacturers and importers shall ensure that products bear an indication of the country of origin of the product and its constituent materials or, where the size or nature of the product does not allow it, that indication is to be provided on the packaging or in a document accompanying the product. The relevant indication shall in every case be affixed visibly and be easily identifiable by the consumer.
Amendment 192 #
Proposal for a regulation Article 7 – paragraph 1 1. Manufacturers and importers shall ensure that products bear an indication of the country of origin of the product or, where the size or nature of the product does not allow it, that indication is to be provided on the packaging or in a document accompanying the product. Manufacturers and importers shall also affix on products an indication of the origin of the constituent materials. The indication of origin of the finished product must be clearly visible to the consumer.
Amendment 193 #
Proposal for a regulation Article 7 – paragraph 1 1. Manufacturers and importers shall ensure that products bear an indication of the country of origin of the product or, including the origin of the raw material used for the production, where the size or nature of the product does not allow it, that indication is to be provided on the packaging or in a document accompanying the product.
Amendment 194 #
Proposal for a regulation Article 7 – paragraph 1 1. Manufacturers and importers must indicate the country of origin of a product to ensure the traceability of a product within the supply chain. Manufacturers and importers shall ensure that all products – irrespective of whether they originate in the EU or in a third country – bear an indication of the country of origin of the product or, where the size or nature of the product
Amendment 195 #
Proposal for a regulation Article 7 – paragraph 1 1. Manufacturers and importers shall ensure that products bear an indication of the country of origin of the product and its constituent materials or, where the size or nature of the product does not allow it, that indication is to be provided on the packaging or in a document accompanying the product.
Amendment 196 #
Proposal for a regulation Article 7 – paragraph 2 2. For the purpose of determination of the country of origin within the meaning of paragraph 1, non-preferential origin rules set out in Articles 52
Amendment 197 #
Proposal for a regulation Article 7 – paragraph 3 3. Where the country of origin determined in accordance with paragraph 2 is a Member State of the Union, manufacturers and importers may refer to the Union or to a particular Member State on the 'made in …’ label. The name and address of the manufacturer should likewise be indicated on all products which are made available on the EU internal market.
Amendment 198 #
Proposal for a regulation Article 7 – paragraph 3 3. Where the country of origin determined in accordance with paragraph 2 is a Member State of the Union, manufacturers and importers m
Amendment 199 #
Proposal for a regulation Article 7 – paragraph 3 a (new) 3a. Manufacturers shall be authorised to indicate the origin in English alone (‘Made in [country]’), since this is readily comprehensible for consumers.
Amendment 200 #
Proposal for a regulation Article 8 – paragraph 1 1.
Amendment 201 #
Proposal for a regulation Article 8 – paragraph 1 a (new) 1a. Manufacturers shall provide consumers with sufficient information allowing them to assess the risks inherent to a product in the course of its normal or foreseeable use, where such risks are not immediately evident without proper warning, so that they can take precautions against such risks. Manufacturers shall assess the risks posed by products before placing them on the market.
Amendment 202 #
Proposal for a regulation Article 8 – paragraph 2 2. Manufacturers shall ensure that procedures are in place for
Amendment 203 #
Proposal for a regulation Article 8 – paragraph 2 2. Manufacturers shall ensure that procedures are in place for series production to remain in conformity with the general safety requirement laid down in Article 4. Manufacturers shall keep a register of checks carried out on batches and be available to the surveillance authorities when required
Amendment 204 #
Proposal for a regulation Article 8 – paragraph 2 a (new) 2a. In order to identify the risks which may possibly be presented by a product, manufacturers shall perform appropriate procedures and shall ascertain the safety of the product and its compliance with the standards referred to in paragraph 2; the Commission shall be empowered to adopt delegated acts in accordance with Article 20 specifying the aspects to be examined by the manufacturer when analysing the possible risks, including the format of the analysis.
Amendment 205 #
Proposal for a regulation Article 8 – paragraph 3 3.
Amendment 206 #
Proposal for a regulation Article 8 – paragraph 3 3. Proportionate to the possible risks of a product, manufacturers shall, to protect the health and safety of consumers, at least once a year, in the presence of a qualified State representative, carry out random sample testing of products made available on the market, investigate complaints and keep a register of complaints, non- conforming products and product recalls, and shall keep distributors informed of any such monitoring. In particular, manufacturers must perform tests under the same conditions for products which have been or are the subject of a Commission decision pursuant to Article 12 of the Regulation on the market surveillance of products.
Amendment 207 #
Proposal for a regulation Article 8 – paragraph 3 3. Proportionate to the possible risks of a product, manufacturers shall, to protect the health and safety of consumers, carry out sample testing
Amendment 208 #
Proposal for a regulation Article 8 – paragraph 3 3. Proportionate to the possible risks of a product, manufacturers shall, to protect the health and safety of consumers, carry out sample testing
Amendment 209 #
Proposal for a regulation Article 8 – paragraph 3 3.
Amendment 210 #
Proposal for a regulation Article 8 – paragraph 3 3. Proportionate to the possible risks of a product, manufacturers shall, to protect the health and safety of consumers, carry out representative sample testing of products made available on the market chosen under the control of a judicial officer or any qualified person designated by each Member State, investigate complaints and
Amendment 211 #
Proposal for a regulation Article 8 – paragraph 3 a (new) 3a. When the products made available on the market are or have been subject to a decision by the Commission on the basis of article 12 of [Regulation on market surveillance of products], manufacturers, or when appropriate importers, shall, to protect the health and safety of consumers, carry out at least once a year representative sample testing of products made available on the market chosen under the control of a judicial officer or any qualified person designated by each Member State.
Amendment 212 #
Proposal for a regulation Article 8 – paragraph 4 – subparagraph 1 – introductory part Proportionate to the possible risks of a product, manufacturers shall draw up a technical documentation for categories of products. The technical documentation shall contain, as appropriate:
Amendment 213 #
Proposal for a regulation Article 8 – paragraph 4 – subparagraph 1 – introductory part Proportionate to the possible risks of a product, manufacturers shall draw up a technical documentation. The technical documentation shall contain
Amendment 214 #
Proposal for a regulation Article 8 – paragraph 4 – subparagraph 1 – introductory part Amendment 215 #
Proposal for a regulation Article 8 – paragraph 4 – subparagraph 1 – point a (a) a general description of the product category and its essential properties relevant for assessing the
Amendment 216 #
Proposal for a regulation Article 8 – paragraph 4 – subparagraph 1 – point a (a) a general description of the product
Amendment 217 #
Proposal for a regulation Article 8 – paragraph 4 – subparagraph 1 – point a a (new) (aa) Name and address of manufacturer. The technical documentation shall be provided in the language of the Member State in which the product is marketed or in one acceptable to the market surveillance authorities by which it is requested.
Amendment 218 #
Proposal for a regulation Article 8 – paragraph 4 – subparagraph 1 – point b (b) an analysis of the possible risks related to the product category and the solutions adopted to eliminate or mitigate such risks, including the outcome of any tests conducted by the manufacturer or by another party on his behalf;
Amendment 219 #
Proposal for a regulation Article 8 – paragraph 4 – subparagraph 1 – point b (b) an analysis of the possible risks related to the product pursuant to [paragraph 2a]*and the solutions adopted to eliminate or mitigate such risks, including the outcome of any tests conducted by the manufacturer or by another party on his behalf; __________________ * Please insert the paragraph which corresponds to Amendment 16 concerning Article 8, paragraph 2a (new), by Josef Weidenholzer.
Amendment 220 #
Proposal for a regulation Article 8 – paragraph 4 – subparagraph 1 – point c (c) where applicable, a list of the European standards referred to in point (b) of Article 5 or health and safety requirements laid down in the law of the Member State where the product
Amendment 221 #
Proposal for a regulation Article 8 – paragraph 4 – subparagraph 1 – point c a (new) (ca) Where the manufacturer does not place the product on the market, name, registered trade name or registered trade mark of the manufacturer and the address at which he can be contacted.
Amendment 222 #
Proposal for a regulation Article 8 – paragraph 4 – subparagraph 2 Where any of the European standards, health and safety requirements or other aspects referred to in point (c) of the first subparagraph have been only partly applied, the parts which have been applied shall be identified and, where appropriate, details shall be provided on how the risks covered by the parts which have not been applied have been taken into account.
Amendment 223 #
Proposal for a regulation Article 8 – paragraph 5 5. Manufacturers shall keep, for a period of ten years after the product has been placed on the market, the technical documentation and make it available to the market surveillance authorities,
Amendment 224 #
Proposal for a regulation Article 8 – paragraph 5 5. Manufacturers shall keep, for a period of ten years after the product has been placed on the market, the technical documentation and make it available to the market surveillance authorities, upon a reasoned request.
Amendment 225 #
Proposal for a regulation Article 8 – paragraph 5 5. Manufacturers shall
Amendment 226 #
Proposal for a regulation Article 8 – paragraph 5 5. Manufacturers shall
Amendment 227 #
Proposal for a regulation Article 8 – paragraph 5 5. Manufacturers shall keep, for a period of ten years after the product has last been placed on the market, the technical documentation and make it available to the market surveillance authorities, upon request.
Amendment 228 #
Proposal for a regulation Article 8 – paragraph 6 6. Manufacturers shall ensure that their products bear a type, batch or serial number or other element allowing the identification of the product which is easily visible and legible for consumers, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the product. In this case, it should be recommended that consumers keep the information indicated on the packaging or on the document accompanying the product.
Amendment 229 #
Proposal for a regulation Article 8 – paragraph 6 6. Manufacturers shall ensure that their products bear a product model, type, batch or serial number or other element allowing the identification of the product which is easily visible and legible for consumers, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the product.
Amendment 230 #
Proposal for a regulation Article 8 – paragraph 6 6. Manufacturers shall ensure that their products bear a type, batch or serial number or other element allowing the identification of the product which is easily visible and legible for consumers, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the product, accompanied in this case by the words 'information to be retained'.
Amendment 231 #
Proposal for a regulation Article 8 – paragraph 6 - subparagraph 1 a (new) Where the information allowing the identification of product is not provided directly on the product, manufacturers shall indicate in a sufficiently visible manner that the medium containing this information must be retained.
Amendment 232 #
Proposal for a regulation Article 8 – paragraph 6 a (new) 6a. Where manufacturers consider that their products bear no risks or only a low level of risk, the provisions in paragraphs 3, 4 and 5 shall not apply. In making that assessment the manufacturer must be able to demonstrate its decision to the relevant market surveillance authorities, following a reasoned request, and to its downstream suppliers.
Amendment 233 #
Proposal for a regulation Article 8 – paragraph 6 a (new) 6a. In order to strengthen products safety, manufacturers shall draw up a list of their product models, and make it available to the public and other economic operators by any appropriate means. The manufacturer shall provide the market surveillance authorities, upon request, as well as any economic operator to whom he distributes his products, with evidence supporting the existence of different essential characteristics between its product models.
Amendment 234 #
Proposal for a regulation Article 8 – paragraph 6 a (new) 6a. Manufacturers of products that are subject of a decision by the Commission under Article 12 of the Regulation on the market surveillance of products [XREFX], shall draw up a list of product models, accompanied by a photograph, and make it available to the public and other economic operators by any appropriate means, in particular for products The manufacturer shall provide the market surveillance authorities, upon request, as well as any economic operator to whom he distributes his products, with evidence supporting the existence of different essential characteristics between its models within the meaning of the definition given in Article 3(2) of this Regulation.
Amendment 235 #
Proposal for a regulation Article 8 – paragraph 6 a (new) 6a. Manufacturers shall draw up a list of their product models, accompanied by a photograph, and make it available to the public and other economic operators by any appropriate means, in particular for products that are the subject of a decision by the Commission under Article 12 of the Regulation on the market surveillance of products [XREFX] and for products that are the subject of widespread distribution. The manufacturer shall provide the market surveillance authorities, upon request, as well as any economic operator to whom he distributes his products, with evidence supporting the existence of different essential characteristics between its models within the meaning of the definition given in Article 3(2) of this Regulation.
Amendment 236 #
Proposal for a regulation Article 8 – paragraph 7 7. Manufacturers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product or, where that is not possible, the information will be provided on its packaging or in a
Amendment 237 #
Proposal for a regulation Article 8 – paragraph 7 7. Manufacturers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product
Amendment 238 #
Proposal for a regulation Article 8 – paragraph 7 7.
Amendment 239 #
Proposal for a regulation Article 8 – paragraph 8 – subparagraph 1 Manufacturers shall ensure that their product is accompanied by instructions and safety information in a language or visual format which can be easily understood by consumers, as determined by the Member State in which the product is made available, except where the product can be used safely and as intended by the manufacturer without such instructions and safety information.
Amendment 240 #
Proposal for a regulation Article 8 – paragraph 8 – subparagraph 1 Manufacturers shall ensure that their product is accompanied by instructions and safety information in a language or in such a way which can be easily understood by consumers, as determined by the Member State in which the product is made available, except where the product can be used safely and as intended by the manufacturer without such instructions and safety information.
Amendment 241 #
Proposal for a regulation Article 8 – paragraph 8 – subparagraph 1 Manufacturers shall ensure that their product is accompanied by instructions and safety information addressed to the consumer in a clear and comprehensible manner and in a language which can be easily understood by consumers, as
Amendment 242 #
Proposal for a regulation Article 8 – paragraph 8 a (new) 8a.The instructions and safety information referred to in paragraph 8 shall be conspicuously placed and be readily visible, clearly legible and, where appropriate, indelible. They shall in no way be hidden, obscured, truncated or separated by other written or pictorial or any other matter.
Amendment 243 #
Proposal for a regulation Article 8 – paragraph 9 9. Manufacturers who consider or have reason to believe that a product which they
Amendment 244 #
Proposal for a regulation Article 8 – paragraph 9 9. Manufacturers who consider or have reason to believe that a product which they have placed on the market is not safe or is otherwise not in conformity with this Regulation shall immediately take the corrective action necessary to bring that product into conformity, to withdraw it or recall it
Amendment 245 #
Proposal for a regulation Article 8 – paragraph 9 9. Manufacturers who consider or have reason to believe that a product which they have placed on the market is not safe or is otherwise not in conformity with this Regulation shall immediately take the corrective action necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product is not safe, manufacturers shall immediately inform the market surveillance authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the risk to health and safety and of any corrective action taken. In urgent cases or where the manufacturer fails to comply with this obligation, Member States shall require the manufacturer to take corrective measures pursuant to Article 9(3) of Regulation (EU) No [.../… of the European Parliament and of the Council of … concerning market surveillance of products]*. __________________ * Note to OJ: please insert the number, date and reference of the Regulation on MSP (COD 2013/0048).
Amendment 246 #
Proposal for a regulation Article 8 – paragraph 9 9. Manufacturers who consider or have reason to believe that a product which they have placed on the market is not safe or is otherwise not in conformity with this Regulation shall immediately take the corrective action necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Manufacturers shall ensure that they have procedures in place for taking corrective action, withdrawing or recalling their products. Furthermore, where the product is not safe, manufacturers shall immediately inform the market surveillance authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the risk to health and safety and of any corrective action taken.
Amendment 247 #
Proposal for a regulation Article 8 – paragraph 9 9.
Amendment 248 #
Proposal for a regulation Article 8 – paragraph 9 9. Manufacturers who consider or have reason to believe that a product which they have placed on the market is not safe or is otherwise not in conformity with this Regulation shall immediately take the corrective action necessary to bring that product into conformity, to withdraw it or recall it,
Amendment 249 #
Proposal for a regulation Article 8 – paragraph 9 9. Manufacturers who consider or have reason to believe that a product which they have placed on the market is not safe or is otherwise not in conformity with this Regulation shall immediately take the corrective action necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. They also shall undertake appropriate actions in order to warn consumers about the danger this product may represent to them. Furthermore, where the product is not safe, manufacturers shall immediately inform the market surveillance authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the risk to health and safety and of any corrective action taken.
Amendment 250 #
Proposal for a regulation Article 8 – paragraph 9 9. Manufacturers who consider or have reason to believe that a product which they have placed on the market is not safe or is otherwise not in conformity with this Regulation shall immediately take the corrective action necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where
Amendment 251 #
Proposal for a regulation Article 8 – paragraph 9 9. Manufacturers who consider or have reason to believe that a product which they have placed on the market is not safe or is otherwise not in conformity with this Regulation shall immediately take the corrective action necessary to bring that product into conformity, to withdraw it or recall it,
Amendment 252 #
Proposal for a regulation Article 8 – paragraph 9 9. Manufacturers who consider or have reason to believe that a product which they have placed on the market is not safe or is otherwise not in conformity with this Regulation shall immediately take the corrective action necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product is not safe, manufacturers shall immediately inform the market surveillance authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the risk to health and safety and of any corrective action taken and of the results of such corrective action.
Amendment 253 #
Proposal for a regulation Article 8 – paragraph 9 a (new) 9a. Manufacturers shall ensure that they have procedures in place for taking corrective action, withdrawing or recalling their products and make them available to the market surveillance authorities, upon request.
Amendment 254 #
Proposal for a regulation Article 8 – paragraph 9 a (new) 9a. As appropriate in the light of the potential risk posed by a product, manufacturers shall regularly obtain information both about the state of the art and technology and about rules and standards to be applied pursuant to Article 6(2).
Amendment 255 #
Proposal for a regulation Article 9 – paragraph 2 – point a (a) further to a reasoned request from a market surveillance authority, provide that authority with all the information and documentation necessary to demonstrate
Amendment 256 #
Proposal for a regulation Article 10 – paragraph 1 1. Before placing a product on the market importers shall ensure that the product is compliant with the general safety requirement laid down in Article 4
Amendment 257 #
Proposal for a regulation Article 10 – paragraph 1 1. Before placing a product on the market importers shall ensure that the product is compliant with the general safety requirement laid down in Article 4 and that the manufacturer has complied with the requirements set out in Article 8(4)
Amendment 258 #
Proposal for a regulation Article 10 – paragraph 1 1. Before placing a product on the market importers shall ensure that the product is compliant with the general safety requirement laid down in Article 4 and that the manufacturer has complied with the requirements set out in Article 8
Amendment 259 #
Proposal for a regulation Article 10 – paragraph 1 1. Before placing a product on the market importers shall ensure that the product is compliant with the general safety requirement laid down in Article 4
Amendment 260 #
Proposal for a regulation Article 10 – paragraph 3 3. Importers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product or, where that is not possible, on its packaging or in a document accompanying the product or on a website clearly indicated on the product or its packaging or accompanying documents. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer.
Amendment 261 #
Proposal for a regulation Article 10 – paragraph 3 3. Importers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product or
Amendment 262 #
Proposal for a regulation Article 10 – paragraph 3 a (new) 3a. Importers shall ensure that their products bear a type, batch or serial number or other element allowing the identification of the product which is easily visible and legible for consumers, or, where the size or nature of the product does not allow it, that the required information is provided on the packaging or in a document accompanying the product.
Amendment 263 #
Proposal for a regulation Article 10 – paragraph 3 a (new) 3a. Importers shall ensure that their products bear a type, batch or serial number or other element allowing the identification of the product which is easily visible and legible for consumers, or that the required information is provided on the packaging or in a document accompanying the product.
Amendment 264 #
Proposal for a regulation Article 10 – paragraph 4 – subparagraph 1 Importers shall ensure that the product is
Amendment 265 #
Proposal for a regulation Article 10 – paragraph 6 6. Proportionate to the possible risks presented by a product, importers shall, to protect the health and safety of persons, carry out sample testing of marketed products, at least once a year on representative samples of the products put up for sale picked randomly under the control of a judicial officer, an authority or any other qualified person designated by each Member State, investigate complaints, and keep a register of complaints, of non-
Amendment 266 #
Proposal for a regulation Article 10 – paragraph 6 6. Proportionate to the possible risks presented by a product, importers shall, to protect the health and safety of persons, carry out sample testing of marketed products, at least once a year on representative samples of the products put up for sale picked randomly under the control of a judicial officer, an authority or any other qualified person designated by each Member State, investigate complaints, and keep a register of complaints, of non-
Amendment 267 #
Proposal for a regulation Article 10 – paragraph 6 6. Proportionate to the possible risks presented by a product, importers shall, to protect the health and safety of persons, carry out sample testing of marketed products, at least once a year on representative samples of the products put up for sale picked randomly under the control of a judicial officer, an authority or any other qualified person designated by each Member State, investigate complaints, and keep a register of complaints, of non-
Amendment 268 #
Proposal for a regulation Article 10 – paragraph 6 6. Proportionate to the possible risks presented by a product, importers shall, to protect the health and safety of persons, carry out representative sample testing of randomly picked marketed products, investigate complaints, and keep a register of complaints, of non-
Amendment 269 #
Proposal for a regulation Article 10 – paragraph 7 7. Importers who consider or have reason to believe that a product which they have placed on the market is not safe or is otherwise not in conformity with this Regulation shall immediately take the corrective action necessary to bring that product into conformity, to withdraw it or recall it,
Amendment 270 #
Proposal for a regulation Article 10 – paragraph 7 7. Importers who consider or have reason to believe that a product which they have placed on the market is not safe or is otherwise not in conformity with this Regulation shall immediately take the
Amendment 271 #
Proposal for a regulation Article 10 – paragraph 7 7. Importers who consider or have reason to believe that a product which they have placed on the market is not safe or is otherwise not in conformity with this Regulation shall immediately take the corrective action necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product is not safe, importers shall immediately inform the market surveillance authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the risk to health and safety and of any corrective action taken.
Amendment 272 #
Proposal for a regulation Article 10 – paragraph 7 7. Importers who consider or have reason to believe that a product which they have placed on the market is not safe or is otherwise not in conformity with this Regulation shall immediately take the corrective action necessary to bring that product into conformity, to withdraw it or recall it
Amendment 273 #
Proposal for a regulation Article 10 – paragraph 7 7. Importers who consider or have reason to believe that a product which they have placed on the market is not safe or is otherwise not in conformity with this
Amendment 274 #
Proposal for a regulation Article 10 – paragraph 7 7. Importers who consider or have reason to believe that a product which they have placed on the market is not safe or is otherwise not in conformity with this Regulation shall immediately take the corrective action necessary to bring that product into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the product is not safe, importers shall immediately inform the market surveillance authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the risk to health and safety and of any corrective action taken, and of the results of such corrective action.
Amendment 275 #
Proposal for a regulation Article 10 – paragraph 8 8. Importers shall
Amendment 276 #
Proposal for a regulation Article 10 – paragraph 8 8. Importers shall
Amendment 277 #
Proposal for a regulation Article 10 – paragraph 8 8. Importers shall
Amendment 278 #
Proposal for a regulation Article 10 – paragraph 8 a (new) 8a. Importers shall draw up lists of their product models, accompanied by a photograph, and make them available to the public and other economic operators by any appropriate means, in particular for products that are the subject of a decision by the Commission under Article 12 of the Regulation on the market surveillance of products and for products that are the subject of widespread distribution. The importer shall provide the market surveillance authorities, upon request, as well as any economic operator to whom he distributes his products, with evidence supporting the existence of essential differences between its models
Amendment 279 #
Proposal for a regulation Article 11 – paragraph 1 1.
Amendment 280 #
Proposal for a regulation Article 11 – paragraph 2 2. Before making a product available on the market distributors shall verify that the
Amendment 281 #
Proposal for a regulation Article 11 – paragraph 2 2. Before making a product available on the market distributors shall verify that the manufacturer and the importer have complied with the requirements set out in Article 8(6), (7) and (8) and Article 10(3) and (4)
Amendment 282 #
Proposal for a regulation Article 11 – paragraph 2 2. Before making a product available on the market distributors shall verify that the
Amendment 283 #
Proposal for a regulation Article 11 – paragraph 2 2. Before making a product available on the market distributors shall
Amendment 284 #
Proposal for a regulation Article 11 – paragraph 2 2. Before making a product available on the market, distributors shall verify that the
Amendment 285 #
Proposal for a regulation Article 11 – paragraph 2 2. Before making a product available on the market distributors shall verify that the manufacturer and the importer have complied with the requirements set out in Article 8(6), (7) and (8) and Article 10(3) and (4), as applicable. Distributors shall not obscure compulsory information or safety-related information provided by the manufacturer or the importer.
Amendment 286 #
Proposal for a regulation Article 11 – paragraph 2 2. Before making a product available on the market distributors shall verify that the
Amendment 287 #
Proposal for a regulation Article 11 – paragraph 2 a (new) 2a. For products that are or have been the subject of a decision by the Commission under Article 12 of the Regulation on market surveillance of products [XREFX], distributors shall, to protect the health and safety of consumers, carry out sample testing at least once a year on representative samples of the products put up for sale picked randomly under the control of a judicial officer, an authority or any other qualified person designated by each Member State.
Amendment 288 #
Proposal for a regulation Article 11 – paragraph 3 3. Where a distributor considers or has a reason to believe that a product is not in conformity with this Regulation, he shall not make the product available on the market until it has been brought into
Amendment 289 #
Proposal for a regulation Article 11 – paragraph 3 3. Where a distributor considers or has a reason to believe that a product is not in conformity with this Regulation, he shall not make the product available on the market until it has been brought into conformity. Furthermore, where the product is not safe, the distributor shall inform the manufacturer or the importer, as applicable, to that effect as well as the market surveillance authority of the Member State in which the distributor is established. Where the product is or has been the subject of a decision by the Commission under Article 12 of the Regulation on market surveillance of products XREFX, distributors shall, to protect the health and safety of consumers, carry out sample testing at least once a year on representative samples of the product put up for sale picked randomly under the control of a judicial officer, an authority or any other qualified person designated by each Member State.
Amendment 290 #
Proposal for a regulation Article 11 – paragraph 4 4. Distributors shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the general safety requirement laid down in Article 4 and its conformity with Article 8(6), (7) and (8) and Article 10(3) and (4)
Amendment 291 #
Proposal for a regulation Article 11 – paragraph 4 a (new) 4a. Depending on the risks that a product is likely to pose, distributors may, in order to protect the health and safety of consumers, test products made available on the market, taking random samples.
Amendment 292 #
Proposal for a regulation Article 11 – paragraph 4 a (new) 4a. Distributors shall ensure that they have procedures in place for taking corrective action, withdrawing or recalling their products and make them available to the market surveillance authorities, upon request
Amendment 293 #
Proposal for a regulation Article 11 – paragraph 5 5. Distributors who consider or have reason to believe that a product which they have made available on the market is not safe or is not in conformity with Article 8(6), (7) and (8) and Article 10(3) and (4), as applicable, shall make sure that the
Amendment 294 #
Proposal for a regulation Article 11 – paragraph 5 5. Distributors who consider or have reason to believe that a product which they have made available on the market is not safe or is not in conformity with Article 8(6), (7) and (8) and Article 10(3) and (4)
Amendment 295 #
Proposal for a regulation Article 11 – paragraph 5 5. Distributors who consider or have reason to believe that a product which they have made available on the market is not safe or is not in conformity with Article 8(6), (7) and (8) and Article 10(3) and (4), as applicable, shall make sure that the corrective action necessary to bring that product into conformity is taken, to withdraw it or recall it, if appropriate. Furthermore, where the product is not safe, distributors shall immediately inform the manufacturer or importer, as applicable as well as market surveillance authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the risk to health and safety and of any corrective action taken. In urgent cases or where the distributor fails to comply with this obligation, Member States shall require the distributor to take corrective measures pursuant to Article 9(3) of Regulation (EU) No [.../… of the European Parliament and of the Council of … concerning market surveillance of products]*. __________________ * Note to OJ: please insert the number, date and reference of the Regulation on MSP (COD 2013/0048).
Amendment 296 #
Proposal for a regulation Article 11 – paragraph 5 5. Distributors who consider or have reason to believe that a product which they have made available on the market is not safe or is not in conformity with Article 8(6), (7) and (8) and Article 10(3) and (4), as applicable, shall make sure that the corrective action necessary to bring that product into conformity is taken, to withdraw it or recall it, if appropriate. Distributors shall ensure that they have procedures for taking corrective action, withdrawing or recalling products that they have made available on the market. Furthermore, where the product is not safe, distributors shall immediately inform the manufacturer or importer, as applicable as well as market surveillance authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the risk to health and safety and of any corrective action taken.
Amendment 297 #
Proposal for a regulation Article 11 – paragraph 5 5. Distributors who consider or have reason
Amendment 298 #
Proposal for a regulation Article 11 – paragraph 5 5. Distributors who consider or have reason to believe that a product which they have made available on the market is not safe or is not in conformity with Article 8(6), (7) and (8) and Article 10(3) and (4), as applicable, shall immediately make sure that the corrective action necessary to bring that product into conformity is taken, to withdraw it or recall it, if appropriate. Furthermore, where the product is not safe, distributors shall immediately inform the manufacturer or importer, as applicable as well as market surveillance authorities of the Member States in which they made the product available to that effect, giving details, in particular, of the risk to health and safety and of any corrective action
Amendment 299 #
Proposal for a regulation Article 11 – paragraph 5 a (new) 5a. Alternatively, distributors may request a professional association which they are a member of, or organise themselves in a professional association for the collective entity, to fulfil their obligations under this article.
Amendment 300 #
Proposal for a regulation Article 11 – paragraph 5 a (new) 5a. Alternatively, distributors may join a professional association in order to fulfil the obligations incumbent upon them pursuant to this article.
Amendment 301 #
Proposal for a regulation Article 11 – paragraph 5 a (new) 5a. Alternatively, distributors may request a professional association which they are a member of, or organise themselves in a professional association for the collective entity, to fulfil their obligations under this article.
Amendment 302 #
Proposal for a regulation Article 11 – paragraph 5 a (new) 5a. Alternatively, distributors may request a professional association which they are a member of, or organise themselves in a professional association for the collective entity, to fulfil their obligations under this article.
Amendment 303 #
Proposal for a regulation Article 12 – title Amendment 304 #
Proposal for a regulation Article 12 – title Cases in which obligations of manufacturers apply to importers and distributors and vice versa
Amendment 305 #
Proposal for a regulation Article 12 – paragraph -1 (new) At the request of the competent authority of a Member State concerning the conformity of a particular product, economic operators shall designate a person to act as a contact. This person may be identical to the person referred to in paragraph 1.
Amendment 306 #
Proposal for a regulation Article 12 – paragraph -1 a (new) Economic operators shall designate a general product safety officer and shall inform the competent authority of a Member State of the officer’s identity. Member States may adopt further provisions on this subject.
Amendment 307 #
Proposal for a regulation Article 12 – paragraph 1 a (new) Manufacturers marketing under their own name or trademark a product previous placed on the EU market by another economic operator shall be considered as importers and hence subject to the relevant obligations under Article 10.
Amendment 308 #
Proposal for a regulation Article 13 – paragraph 1 Amendment 309 #
Proposal for a regulation Article 13 – paragraph 1 – introductory part 1. Obligation to inform the market surveillance authorities in accordance with Article 8(9), Article 10(2) and (7) and Article 11(3) and (5) shall not apply where the
Amendment 310 #
Proposal for a regulation Article 13 – paragraph 1 – introductory part 1. Obligation to inform the market surveillance authorities in accordance with Article 8(9), Article 10(2) and (7) and Article 11(3) and (5) shall not apply in the case of minimum risks compatible with the product's use, considered acceptable and consistent with a high level of protection of health and safety of persons in accordance with Article 3, paragraph 1, or where the following conditions are fulfilled:
Amendment 311 #
Proposal for a regulation Article 13 – paragraph 1 – point a Amendment 312 #
Proposal for a regulation Article 13 – paragraph 1 – point b Amendment 313 #
Proposal for a regulation Article 13 – paragraph 1 – point b (b) the manufacturer, importer or distributor can demonstrate that the risk has been
Amendment 314 #
Proposal for a regulation Article 13 – paragraph 1 – point b (b) the manufacturer, importer or distributor can demonstrate that the risk has been
Amendment 315 #
Proposal for a regulation Article 13 – paragraph 1 – point c Amendment 316 #
Proposal for a regulation Article 13 – paragraph 1 – point c Amendment 317 #
Proposal for a regulation Article 13 – paragraph 2 Amendment 318 #
Proposal for a regulation Article 13 – paragraph 3 Amendment 319 #
Proposal for a regulation Article 13 – paragraph 3 Amendment 320 #
Proposal for a regulation Article 13 – paragraph 3 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 20 determining the products, categories or groups of products for which, due to their low level of risk, the information referred to in Article 8(7) and Article 10(3)
Amendment 321 #
Proposal for a regulation Article 13 – paragraph 3 3. The Commission shall be empowered to adopt delegated acts in accordance with Article 20 determining the products, categories or groups of products for which
Amendment 322 #
Proposal for a regulation Article 14 – paragraph 1 – introductory part 1. Economic operators shall, on request,
Amendment 323 #
Proposal for a regulation Article 14 – paragraph 1 – point a (a) any economic operator who has supplied them with the product; the nature and number of the products supplied and all traceability indications;
Amendment 324 #
Proposal for a regulation Article 14 – paragraph 1 – point a (a) the identity of any economic operator who has supplied them with the product, and the number of products involved and any complementary traceability information available;
Amendment 325 #
Proposal for a regulation Article 14 – paragraph 1 – point b (b) any economic operator to whom they have supplied
Amendment 326 #
Proposal for a regulation Article 14 – paragraph 1 – point b (b) the identity of any economic operator to whom they have supplied the product
Amendment 327 #
Proposal for a regulation Article 14 – paragraph 2 2. Economic operators shall be able to present the information referred to in the first paragraph for a period of
Amendment 328 #
Proposal for a regulation Article 14 – paragraph 2 2. Economic operators shall be able to present the information referred to in the first paragraph for a period
Amendment 329 #
Proposal for a regulation Article 14 – paragraph 2 a (new) 2a. Where economic operators identify the information referred to in the first paragraph, the market surveillance authorities shall treat this information as confidential.
Amendment 330 #
Proposal for a regulation Article 15 Amendment 331 #
Proposal for a regulation Article 15 – paragraph 1 1. For certain products, categories or
Amendment 332 #
Proposal for a regulation Article 15 – paragraph 1 1. For certain products, categories or groups of products and particularly those which, due to their specific characteristics or specific conditions of distribution or usage, susceptible to bear a serious risk to health and safety of persons, the Commission may require economic operators who place and make available those products on the market to establish or adhere to a system of traceability.
Amendment 333 #
Proposal for a regulation Article 15 – paragraph 2 2. The system of traceability shall consist of the collection and storage of data by electronic means enabling the identification of the product and of the economic operators involved in its supply chain as well as of the placement of a data carrier on the product, its packaging or accompanying documents enabling access to that data. The system of traceability shall include facilities to extend traceability of products out to the consumer through voluntary opt-in measures.
Amendment 334 #
Proposal for a regulation Article 15 – paragraph 2 a (new) 2a. The system of traceability shall include facilities to extend traceability of products out to the consumer through voluntary opt-in measures.
Amendment 335 #
Proposal for a regulation Article 15 – paragraph 3 – point a (a) determining the products, categories or groups of products
Amendment 336 #
Proposal for a regulation Article 15 – paragraph 3 – point a (a) determining the products, categories or groups of products susceptible to bear a serious risk to health and safety of persons as referred to in paragraph 1. The Commission shall state in the delegated acts concerned if it has used the risk analysis methodology provided for in Decision 2010/15/EU or, if this method is not appropriate for the product concerned, it shall give a detailed description of the method used;
Amendment 337 #
Proposal for a regulation Article 16 – paragraph 1 – subparagraph 1 The Commission may request one or several European standardisation organisations to draft or identify a European standard, which aims at ensuring that products that conform to such standard or parts thereof comply with the general safety requirement laid down in Article 4. Taking into account the views of relevant stakeholders, as appropriate, the Commission shall determine the requirements as to the content to be met by the requested European standard and a deadline for its adoption.
Amendment 338 #
Proposal for a regulation Article 16 – paragraph 1 – subparagraph 1 The Commission may request one or several European standardisation organisations to draft or identify a European standard, which aims at ensuring that products that conform to such standard or parts thereof comply with the general
Amendment 339 #
Proposal for a regulation Article 16 – paragraph 1 – subparagraph 2 The Commission shall adopt the request referred to in the first subparagraph by a
Amendment 340 #
Proposal for a regulation Article 16 – paragraph 2 2. The relevant European standardisation organisation shall indicate, within one month following receipt of the request referred to in paragraph 1, if it accepts it. If the standardisation organisation does not accept the request referred to in paragraph 1, the Commission may entrust the task to other appropriate operators.
Amendment 341 #
Proposal for a regulation Article 16 – paragraph 5 5. Where the European standard satisfies both the requirements it aims to cover and the general safety requirement laid down in Article 4, and this is confirmed by the committee referred to in Article 19(1), first subparagraph, in accordance with Article 19(3), the Commission shall publish a reference to such European standard without delay in the Official Journal of the European Union.
Amendment 342 #
Proposal for a regulation Article 18 Amendment 343 #
Proposal for a regulation Article 18 – paragraph 2 Amendment 344 #
Proposal for a regulation Article 18 – paragraph 2 2. The penalties referred to in paragraph 1 shall have regard to the size and turnover of the undertakings, a
Amendment 345 #
Proposal for a regulation Article 18 – paragraph 2 2. The penalties referred to in paragraph 1 shall have regard to the size of the undertakings and in particular to the situation of small and medium-sized enterprises. The penalties may be increased if the relevant economic operator has previously committed a similar infringement and may include criminal sanctions for serious infringements. The penalties may also be increased in proportion to number and value and to the period for which a product has been made available on the market.
Amendment 346 #
Proposal for a regulation Article 18 – paragraph 2 2. The penalties referred to in paragraph 1 shall have regard to the
Amendment 347 #
Proposal for a regulation Article 18 – paragraph 2 2. The penalties referred to in paragraph 1 shall have regard to the
Amendment 348 #
Proposal for a regulation Article 18 – paragraph 2 2. The penalties referred to in paragraph 1 shall have regard to the gravity of the infringement, to the size of the undertakings and in particular to the situation of small and medium-sized enterprises, as well as the actual operations carried out by economic operators as part of the production process and the extent to which they are in a position ot affect product safety. The penalties may be increased if the relevant economic operator responsible for first placing the product on the market has previously committed a similar infringement and may include criminal
Amendment 349 #
Proposal for a regulation Article 18 – paragraph 2 2. The penalties referred to in paragraph 1 shall have regard to the size and situation of the undertaking
Amendment 350 #
Proposal for a regulation Article 18 – paragraph 2 2. The penalties referred to in paragraph 1 shall have regard to the gravity of the infringement, the turnover and size of the undertakings and in particular to the situation of small and medium-sized enterprises, as well as the actual operations carried out by economic operators as part of the production process and the extent to which they are in a position ot affect product safety. The penalties may be increased if the relevant economic operator responsible for first placing the product on the market has previously committed a similar
Amendment 351 #
Proposal for a regulation Article 18 – paragraph 2 2. The penalties referred to in the first subparagraph
Amendment 352 #
Proposal for a regulation Article 19 – paragraph 1 – subparagraph 2 However, for the purposes of Articles 16 and 17 of this Regulation the Commission shall be assisted by the Committee established by Regulation (EU) No 1025/2012. That Committee shall be a
Amendment 353 #
Proposal for a regulation Article 20 – paragraph 3 3. The delegation of power referred to in Article
Amendment 76 #
Proposal for a regulation Recital 6 (6) This Regulation should not cover services. However, in order to secure the attainment of the protection of health and safety of consumers, it should apply to products that are supplied or made available to consumers in the context of the provision of services, including products to which consumers are directly exposed during a service provision.
Amendment 77 #
Proposal for a regulation Recital 7 (7) Despite the development of sector- specific Union harmonisation legislation that addresses safety aspects of specific products or categories of products, it is practically impossible to adopt Union legislation for all consumer products that exist or may be developed. There is therefore still a need for a legislative framework of a horizontal nature to
Amendment 78 #
Proposal for a regulation Recital 8 (8) In respect of the consumer products subject to this Regulation the scope of its application
Amendment 79 #
Proposal for a regulation Recital 10 (10) The scope of this Regulation should not be limited to any selling technique of consumer products, and thus also cover distance selling, such as electronic selling, online sales and sales platforms, ...
Amendment 80 #
Proposal for a regulation Recital 10 a (new) Amendment 81 #
Proposal for a regulation Recital 12 (12) This Regulation should also apply to consumer products which, although not foodstuff, resemble foodstuff and are likely to
Amendment 82 #
Proposal for a regulation Recital 12 a (new) (12a) Products are not likely to be used by consumers if they are intended, under reasonably foreseeable conditions, for the exclusive use by professionals and explicitly labelled and presented as such.
Amendment 83 #
Proposal for a regulation Recital 12 a (new) (12a) This Regulation should comply with the marketing ban for cosmetic ingredients and products, especially in regards to testing on animals.
Amendment 84 #
Proposal for a regulation Recital 13 (13) The safety of products should be assessed taking into account all the relevant aspects, in particular their characteristics and presentation as well as the categories of consumers who are likely to use the products under reasonably foreseeable conditions, taking into account their vulnerability, in particular children, the elderly and the disabled.
Amendment 85 #
Proposal for a regulation Recital 13 (13) The safety of products should be assessed taking into account all the relevant aspects, in particular their characteristics, composition and presentation as well as the categories of consumers who are likely to use the products taking into account their vulnerability, in particular children, the elderly and the disabled.
Amendment 86 #
Proposal for a regulation Recital 13 (13) The safety of products should be assessed taking into account all the relevant aspects, in particular their characteristics, authenticity and presentation as well as the categories of consumers who are likely to use the products taking into account their vulnerability, in particular children, the elderly and the disabled.
Amendment 87 #
Proposal for a regulation Recital 13 a (new) (13a) Products subject to Union harmonisation legislation that does not lay down essential requirements but by which or pursuant to which health and safety aspects related to the use of such products should be taken into account, should be presumed to be in compliance with the general safety requirement, provided that they comply with that legislation.
Amendment 88 #
Proposal for a regulation Recital 13 a (new) (13a) This Regulation should take into account 'child-appealing' products, whose design clearly resembles a toy, and although it is not a toy, is likely to be especially appealing to children.
Amendment 89 #
Proposal for a regulation Recital 13 a (new) (13a) Product safety also comprises protection of personal data and associated aspects (e.g. privacy by design).
Amendment 90 #
Proposal for a regulation Recital 13 a (new) (13a) Products specifically intended for children should be assessed for their levels of risk and appropriate action taken to mitigate that risk;
Amendment 91 #
Proposal for a regulation Recital 14 (14) To avoid overlapping safety requirements and conflicts with other Union legislation, a product which
Amendment 92 #
Proposal for a regulation Recital 18 a (new) (18a) The distributor should ensure that the manufacturer and the importer have complied with their obligations, that is to say verifying the indication on product or on its packaging of the name, model name, brand name or address at which the manufacturer and the importer can be contacted and the affixing of the manufacturer's batch number, serial number or other element on the product for the identification of the product. The distributor should not check each product individually, unless the distributor considers that the manufacturer on importer have not fulfilled their requirement.
Amendment 93 #
Proposal for a regulation Recital 18 a (new) (18a) The distributor should ensure that the manufacturer and the importer have complied with their obligations, that is to say verifying the indication on the product or on its packaging of the name, model name, brand name or address at which the manufacturer and the importer can be contacted and the affixing of the manufacturer's batch number, serial number or other element on the product for the identification of the product. The distributor should not check each product individually, unless the distributor considers that the manufacturer or importer have not fulfilled their requirements.
Amendment 94 #
Proposal for a regulation Recital 18 a (new) (18a) The distributor should ensure that the manufacturer and the importer have complied with their obligations, that is to say verifying the indication on the product or on its packaging of the name, model name, brand name or address at which the manufacturer and the importer can be contacted and the affixing of the manufacturer's batch number, serial number or other element on the product for the identification of the product.
Amendment 95 #
Proposal for a regulation Recital 18 a (new) Amendment 96 #
Proposal for a regulation Recital 18 a (new) (18a) The distributor should ensure that the manufacturer and the importer have complied with their obligations, that is to say, in so far as this is not objectively impossible or does not incur unreasonable cost, verifying the indication on the product or on its packaging of the name, brand name or address at which the manufacturer and the importer can be contacted and the affixing of the manufacturer's batch number, serial number or other element on the product for the identification purposes. The distributor should not check each product individually, unless he believes that the manufacturer or importer have not fulfilled their requirements.
Amendment 97 #
Proposal for a regulation Recital 20 (20) It is essential that all products made available on the European internal market should be safe in order to guarantee a high level of consumer protection. Ensuring product identification, indication of origin and the traceability of products throughout the entire supply chain helps to identify economic operators and to take effective corrective measures against unsafe products, such as targeted recalls. Product identification and traceability thus ensure that consumers and economic operators obtain accurate information regarding unsafe products which enhances confidence in the market and avoids unnecessary disruption of trade. Products should therefore bear information allowing their identification and the identification of the manufacturer and, if applicable, of the importer. Manufacturers should also establish technical documentations regarding their products for which they may choose the most appropriate
Amendment 98 #
Proposal for a regulation Recital 20 (20) Ensuring product identification and the traceability of products throughout the entire supply chain helps to identify economic operators and to take effective corrective measures against unsafe products, such as targeted recalls. Product identification and traceability thus ensure that consumers and economic operators obtain accurate information regarding unsafe products which enhances confidence in the market and avoids unnecessary disruption of trade. Products should therefore bear information allowing their identification and the identification of the manufacturer
Amendment 99 #
Proposal for a regulation Recital 21 source: PE-516.922
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6.20.02 Export/import control, trade defence, trade barriers |
activities/4/council |
Competitiveness (Internal Market, Industry, Research and Space)
|
activities/4/docs |
|
activities/4/meeting_id |
3276
|
activities/4/type |
Old
Debate in CouncilNew
Council Meeting |
activities/6/council |
Competitiveness (Internal Market, Industry, Research and Space)
|
activities/6/docs |
|
activities/6/meeting_id |
3353
|
activities/6/type |
Old
Debate in CouncilNew
Council Meeting |
other/0 |
|
activities/0/docs/0/celexid |
CELEX:52013PC0078:EN
|
activities/0/docs/0/celexid |
CELEX:52013PC0078:EN
|
activities/4/council |
Competitiveness (Internal Market, Industry, Research and Space)
|
activities/4/docs |
|
activities/4/meeting_id |
3276
|
activities/4/type |
Old
Council MeetingNew
Debate in Council |
activities/6/council |
Competitiveness (Internal Market, Industry, Research and Space)
|
activities/6/docs |
|
activities/6/meeting_id |
3353
|
activities/6/type |
Old
Council MeetingNew
Debate in Council |
other/0 |
|
procedure/legislative_priorities |
|
procedure/legislative_priorities |
|
procedure/selected_topics |
|
activities/0/commission/0/DG/title |
Old
Enterprise and IndustryNew
Internal Market, Industry, Entrepreneurship and SMEs |
activities/0/commission/0/DG/url |
Old
http://ec.europa.eu/enterprise/New
http://ec.europa.eu/info/departments/internal-market-industry-entrepreneurship-and-smes_en |
other/1/dg/title |
Old
Enterprise and IndustryNew
Internal Market, Industry, Entrepreneurship and SMEs |
other/1/dg/url |
Old
http://ec.europa.eu/enterprise/New
http://ec.europa.eu/info/departments/internal-market-industry-entrepreneurship-and-smes_en |
procedure/Mandatory consultation of other institutions |
Old
Economic and Social CommitteeNew
European Economic and Social Committee |
activities/0/docs/0/url |
Old
http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2013&nu_doc=78New
http://www.europarl.europa.eu/RegData/docs_autres_institutions/commission_europeenne/com/2013/0078/COM_COM(2013)0078_EN.doc |
procedure/subject/0 |
Old
2.10.03 Standardisation, EC standards and trademark, certification, complianceNew
2.10.03 Standardisation, EC/EU standards and trade mark, certification, compliance |
activities/0/docs/0/celexid |
CELEX:52013PC0078:EN
|
activities/0/docs/0/celexid |
CELEX:52013PC0078:EN
|
activities/0/docs/0/celexid |
CELEX:52013PC0078:EN
|
activities/0/docs/0/celexid |
CELEX:52013PC0078:EN
|
links/European Commission/title |
Old
PreLexNew
EUR-Lex |
activities/0/docs/0/celexid |
CELEX:52013PC0078:EN
|
activities/0/docs/0/celexid |
CELEX:52013PC0078:EN
|
activities/6 |
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other/0 |
|
activities/0/body |
Old
EPNew
EC |
activities/0/commission |
|
activities/0/committees |
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activities/0/date |
Old
2013-10-17T00:00:00New
2013-02-13T00:00:00 |
activities/0/docs |
|
activities/0/type |
Old
Vote in committee, 1st reading/single readingNew
Legislative proposal published |
activities/1/committees/2/rapporteur/0/mepref |
Old
4de188790fb8127435bdc34fNew
4f1adb1fb819f207b30000aa |
activities/1/committees/2/shadows/0/mepref |
Old
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4f1ac62ab819f25efd000022 |
activities/1/committees/2/shadows/1/mepref |
Old
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4f1ac752b819f25efd00007d |
activities/1/committees/2/shadows/2/mepref |
Old
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4f1adaefb819f207b300009b |
activities/1/committees/2/shadows/3/mepref |
Old
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4f1ac814b819f25efd0000c7 |
activities/1/committees/2/shadows/4/mepref |
Old
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4f1adafdb819f207b300009f |
activities/1/committees/3/rapporteur/0/mepref |
Old
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4f1ad9e1b819f207b300003f |
activities/1/committees/4/rapporteur/0/mepref |
Old
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4f1adbf8b819f207b30000f4 |
activities/1/committees/5/rapporteur/0/mepref |
Old
4de186c20fb8127435bdc0dbNew
4f1ad979b819f207b300001b |
activities/2/body |
Old
ECNew
EP |
activities/2/commission |
|
activities/2/committees |
|
activities/2/date |
Old
2013-02-13T00:00:00New
2013-10-17T00:00:00 |
activities/2/docs |
|
activities/2/type |
Old
Legislative proposal publishedNew
Vote in committee, 1st reading/single reading |
activities/3/committees/2/rapporteur/0/mepref |
Old
4de188790fb8127435bdc34fNew
4f1adb1fb819f207b30000aa |
activities/3/committees/2/shadows/0/mepref |
Old
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4f1ac62ab819f25efd000022 |
activities/3/committees/2/shadows/1/mepref |
Old
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4f1ac752b819f25efd00007d |
activities/3/committees/2/shadows/2/mepref |
Old
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4f1adaefb819f207b300009b |
activities/3/committees/2/shadows/3/mepref |
Old
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4f1ac814b819f25efd0000c7 |
activities/3/committees/2/shadows/4/mepref |
Old
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4f1adafdb819f207b300009f |
activities/3/committees/3/rapporteur/0/mepref |
Old
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4f1ad9e1b819f207b300003f |
activities/3/committees/4/rapporteur/0/mepref |
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4f1adbf8b819f207b30000f4 |
activities/3/committees/5/rapporteur/0/mepref |
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4f1ad979b819f207b300001b |
committees/2/rapporteur/0/mepref |
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4f1adb1fb819f207b30000aa |
committees/2/shadows/0/mepref |
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4f1ac62ab819f25efd000022 |
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4f1ac752b819f25efd00007d |
committees/2/shadows/2/mepref |
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4f1adaefb819f207b300009b |
committees/2/shadows/3/mepref |
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4f1ac814b819f25efd0000c7 |
committees/2/shadows/4/mepref |
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4f1adafdb819f207b300009f |
committees/3/rapporteur/0/mepref |
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4f1ad9e1b819f207b300003f |
committees/4/rapporteur/0/mepref |
Old
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4f1adbf8b819f207b30000f4 |
committees/5/rapporteur/0/mepref |
Old
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4f1ad979b819f207b300001b |
activities/1/committees/2/shadows/0/group |
Old
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activities/2/committees/2/shadows/0/group |
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activities/2/committees/2/shadows/1/group |
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activities/2/committees/2/shadows/2/group |
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activities/3/committees/2/shadows/0/group |
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activities/3/committees/2/shadows/1/group |
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activities/3/committees/2/shadows/2/group |
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activities/3/committees/2/shadows/3/group |
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activities/3/committees/2/shadows/4/group |
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committees/2/shadows/0/group |
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committees/2/shadows/1/group |
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committees/2/shadows/2/group |
Old
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committees/2/shadows/3/group |
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committees/2/shadows/4/group |
Old
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procedure/subject/0 |
Old
2.10.03 Standardisation, EC standards and trade mark, certification, complianceNew
2.10.03 Standardisation, EC standards and trademark, certification, compliance |
activities/1/committees/2/shadows/0/group |
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activities/1/committees/2/shadows/1/group |
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activities/3/committees/2/shadows/0/group |
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activities/3/committees/2/shadows/1/group |
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activities/3/committees/2/shadows/2/group |
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activities/3/committees/2/shadows/4/group |
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committees/2/shadows/0/group |
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committees/2/shadows/3/group |
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activities/1/committees/2/shadows/0/group |
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activities/1/committees/2/shadows/1/group |
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activities/1/committees/2/shadows/2/group |
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activities/2/committees |
|
activities/2/date |
Old
2014-04-15T00:00:00New
2013-10-17T00:00:00 |
activities/2/docs |
|
activities/2/type |
Old
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Vote in committee, 1st reading/single reading |
activities/3/committees/2/shadows/0/group |
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activities/3/committees/2/shadows/3/group |
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activities/3/committees/2/shadows/4/group |
Old
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EFD |
activities/5/committees |
|
activities/5/date |
Old
2013-10-17T00:00:00New
2014-04-15T00:00:00 |
activities/5/docs |
|
activities/5/type |
Old
Vote in committee, 1st reading/single readingNew
Results of vote in Parliament |
committees/2/shadows/0/group |
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activities/1/committees/2/shadows/0/group |
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activities/1/committees/2/shadows/1/group |
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activities/1/committees/2/shadows/3/group |
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PURPOSE: to ensure the functioning of the internal market as regards products intended for consumers by laying down uniform rules regarding a general safety requirement (product safety and market surveillance package). PROPOSED ACT: Regulation of the European Parliament and of the Council (repealing Council Directive 87/357/EEC and Directive 2001/95/EC on general product safety). ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council. BACKGROUND: the free movement of safe consumer products is one of the cornerstones of the European Union. Directive 2001/95/EC on general product safety (GPSD) lays down the requirement that consumer products must be safe and that Member States' market surveillance authorities must take action against dangerous products as well as exchange information to that effect through the Community rapid information exchange system RAPEX. Overlaps of market surveillance rules and obligations of economic operators laid down in various pieces of Union legislation (the GPSD, the Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and sector-specific Union harmonisation legislation that also covers consumer products) has led to confusion on the part of both economic operators and national authorities and has seriously hampered the effectiveness of market surveillance activity in the Union. The Commission considers that Directive 2001/95/EC needs to be fundamentally revised to improve its functioning and to ensure consistency with developments in Union legislation as regards market surveillance, obligations of economic operators and standardisation. In the interest of clarity, Directive 2001/95/EC should be repealed and replaced by this Regulation. The proposal is part of the "Product Safety and Market Surveillance Package" which also includes a proposal for a single market surveillance regulation and a multiannual action plan for market surveillance covering the period 2013-2015. The Single Market Act II, adopted in 2012, confirms the "Product Safety and Market Surveillance Package" as a key action to improve the safety of products circulating in the EU. IMPACT ASSESSMENT: the impact assessment prepared by the Commission thus covers aspects related to both this proposal and the proposal for a new Market Surveillance Regulation. The Commission's Impact Assessment Board delivered a favourable opinion in September 2012. LEGAL BASIS: Article 114 of the Treaty on the Functioning of the European Union. CONTENT: this proposal for a Regulation on consumer product safety, which will replace Directive 2001/95/EC on general product safety (GPSD), concerns manufactured non-food consumer products. It aims at clarifying the regulatory framework for consumer products taking into account legislative developments in recent years. Like the GPSD, the proposed Regulation requires that consumer products must be "safe", sets certain obligations on economic operators and contains provisions for the development of standards in support of the general safety requirement. The main elements of the proposal are as follows: Scope and definitions: the proposed Regulation clearly delimits its scope of application compared to sectoral Union harmonisation legislation.
General safety requirement and obligations of economic operators: the general requirement, laid down already in the GPSD, that all consumer products must be safe when placed or made available on the Union market has been kept. However, its operation in practice will be significantly simplified due to the introduction of a clear link with sector-specific legislation and a simplification of the rules on standards. On the basis of Decision No 768/2008/EC on a common framework for the marketing of products, the proposal:
Use of European standards: like the GPSD, also the proposal for the new Regulation favours the use of standards in support of the implementation of the general safety requirement. However, the process to identify existing European standards or to ask for the development of European standards that would give rise to presume that a product is safe has been significantly simplified and aligned to Regulation (EU) No 1025/2012 that sets a new overarching framework for European standardisation. Market surveillance and RAPEX: the provisions regarding market surveillance and RAPEX that are currently contained in the GPSD have been transferred to the proposal for a new single Market Surveillance Regulation. That new Regulation would produce a one-tier system in which all market surveillance rules are brought together in a single instrument and in which RAPEX will be the single alert system regarding products presenting a risk. BUDGETARY IMPLICATION: the proposal does not have other budgetary implications than those related to the proper management of the Regulation which, in form of the GPSD, is already part of the Union law acquis. The budgetary implications are already foreseen in the existing or proposed programmes and respect the Commission proposal for the new multiannual financial framework. According to the financial statement, the total appropriations (operational appropriations, human resources and administrative expenditure) amount to EUR 12 019 million in commitments for 2015-2020. DELEGATED ACTS: the proposal contains provisions empowering the Commission to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union. New
PURPOSE: to ensure the functioning of the internal market as regards products intended for consumers by laying down uniform rules regarding a general safety requirement (product safety and market surveillance package). PROPOSED ACT: Regulation of the European Parliament and of the Council (repealing Council Directive 87/357/EEC and Directive 2001/95/EC on general product safety). ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council. BACKGROUND: the free movement of safe consumer products is one of the cornerstones of the European Union. Directive 2001/95/EC on general product safety (GPSD) lays down the requirement that consumer products must be safe and that Member States' market surveillance authorities must take action against dangerous products as well as exchange information to that effect through the Community rapid information exchange system RAPEX. Overlaps of market surveillance rules and obligations of economic operators laid down in various pieces of Union legislation (the GPSD, the Regulation (EC) No 765/2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and sector-specific Union harmonisation legislation that also covers consumer products) has led to confusion on the part of both economic operators and national authorities and has seriously hampered the effectiveness of market surveillance activity in the Union. The Commission considers that Directive 2001/95/EC needs to be fundamentally revised to improve its functioning and to ensure consistency with developments in Union legislation as regards market surveillance, obligations of economic operators and standardisation. In the interest of clarity, Directive 2001/95/EC should be repealed and replaced by this Regulation. The proposal is part of the "Product Safety and Market Surveillance Package" which also includes a proposal for a single market surveillance regulation and a multiannual action plan for market surveillance covering the period 2013-2015. The Single Market Act II, adopted in 2012, confirms the "Product Safety and Market Surveillance Package" as a key action to improve the safety of products circulating in the EU. IMPACT ASSESSMENT: the impact assessment prepared by the Commission thus covers aspects related to both this proposal and the proposal for a new Market Surveillance Regulation. The Commission's Impact Assessment Board delivered a favourable opinion in September 2012. LEGAL BASIS: Article 114 of the Treaty on the Functioning of the European Union. CONTENT: this proposal for a Regulation on consumer product safety, which will replace Directive 2001/95/EC on general product safety (GPSD), concerns manufactured non-food consumer products. It aims at clarifying the regulatory framework for consumer products taking into account legislative developments in recent years. Like the GPSD, the proposed Regulation requires that consumer products must be "safe", sets certain obligations on economic operators and contains provisions for the development of standards in support of the general safety requirement. The main elements of the proposal are as follows: Scope and definitions: the proposed Regulation clearly delimits its scope of application compared to sectoral Union harmonisation legislation.
General safety requirement and obligations of economic operators: the general requirement, laid down already in the GPSD, that all consumer products must be safe when placed or made available on the Union market has been kept. However, its operation in practice will be significantly simplified due to the introduction of a clear link with sector-specific legislation and a simplification of the rules on standards. On the basis of Decision No 768/2008/EC on a common framework for the marketing of products, the proposal:
Use of European standards: like the GPSD, also the proposal for the new Regulation favours the use of standards in support of the implementation of the general safety requirement. However, the process to identify existing European standards or to ask for the development of European standards that would give rise to presume that a product is safe has been significantly simplified and aligned to Regulation (EU) No 1025/2012 that sets a new overarching framework for European standardisation. Market surveillance and RAPEX: the provisions regarding market surveillance and RAPEX that are currently contained in the GPSD have been transferred to the proposal for a new single Market Surveillance Regulation. That new Regulation would produce a one-tier system in which all market surveillance rules are brought together in a single instrument and in which RAPEX will be the single alert system regarding products presenting a risk. BUDGETARY IMPLICATION: the proposal does not have other budgetary implications than those related to the proper management of the Regulation which, in form of the GPSD, is already part of the Union law acquis. The budgetary implications are already foreseen in the existing or proposed programmes and respect the Commission proposal for the new multiannual financial framework. According to the financial statement, the total appropriations (operational appropriations, human resources and administrative expenditure) amount to EUR 12 019 million in commitments for 2015-2020. DELEGATED ACTS: the proposal contains provisions empowering the Commission to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union. |
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