Activities of Guillaume BALAS related to 2014/0108(COD)
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on personal protective equipment
Amendments (31)
Amendment 138 #
Proposal for a regulation
Recital 3 a (new)
Recital 3 a (new)
(3a) This Regulation should apply to all forms of supply, including distance selling.
Amendment 148 #
Proposal for a regulation
Recital 11
Recital 11
(11) Economic operators should be responsible for the compliance of productsPPE, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of public interests, such as health and safety, and the protection of users and to guarantee fair competition on the Union market.
Amendment 150 #
Proposal for a regulation
Recital 12
Recital 12
(12) All economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that PPE protects the health and safety of persons and that they make available on the market only productsPPE which complyies with this Regulation. This Regulation should provide a clear and proportionate distribution of obligations which correspond to the role of each operator in the supply and distribution chain.
Amendment 151 #
Proposal for a regulation
Recital 12 a (new)
Recital 12 a (new)
(12a) In order to facilitate communication between economic operators, market surveillance authorities and consumers, Member States should encourage economic operators to include a website address in addition to the postal address.
Amendment 152 #
Proposal for a regulation
Recital 14
Recital 14
(14) It is necessary to ensure that PPE entering the Union market complies with this Regulation and, in particular, that appropriate assessment procedures have been carried out by manufacturers. Provision should therefore be made for importers to make sure that the PPE they place on the market complies with the requirements of this Regulation and that they do not place on the market PPE which does not comply with such requirements or which present a risk. Provision should also be made for importers to make sure that the conformity assessment procedures have been carried out and that the CE marking and technical documentation drawn up by manufacturers are available for inspection by the markecompetent surveillance authorities.
Amendment 155 #
Proposal for a regulation
Recital 17
Recital 17
(17) Any economic operator that either places PPE on the market under its own name or trademark or modifies a productPPE in such a way that compliance with the requirements of this Regulation may be affected should be considered to be the manufacturer and should assume the obligations of the manufacturer.
Amendment 160 #
Proposal for a regulation
Recital 19
Recital 19
(19) Ensuring traceability of PPE throughout the supply chain helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates the market surveillance authorities' task of tracing economic operators who made non-compliant productPPE available on the market.
Amendment 163 #
Proposal for a regulation
Recital 27
Recital 27
(27) The CE marking should be the only marking indicating that PPE is in conformity with Union harmonisation legislation. However, other markings should be allowed as long as they contribute to the improvement of consumer health and safety protection and are not covered by Union harmonisation legislation.
Amendment 164 #
Proposal for a regulation
Recital 28
Recital 28
(28) In order to ensure compliance with the essential health and safety requirements, it is necessary to lay down appropriate conformity assessment procedures to be followed by the manufacturer. Directive 89/686/EEC classifies PPE into three categories that are subject to different conformity assessment procedures. In order to ensure a consistently high level of safety for all PPE, the list of products subject to one of the conformity assessment procedures relating to the production phase should be enlarged. The conformity assessment procedures for each category of PPE should be set, as far as possible, on the basis of the conformity assessment modules laid down in Decision No 768/2008/EC.
Amendment 176 #
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
This Regulation lays down requirements for the design and manufacture of personal protective equipment (PPE) intended to be placed on the market in order to ensure the health and safety protection of users and rules on its free movement in the Union.
Amendment 181 #
Proposal for a regulation
Article 2 – paragraph 2 – point d
Article 2 – paragraph 2 – point d
d) for use solely on seagoing vessels or aircraft that are subject to the relevant international treaties applicable in Member States;
Amendment 184 #
Proposal for a regulation
Article 3 – paragraph 1 – point 1 – point a
Article 3 – paragraph 1 – point 1 – point a
a) equipment intenddesigned and manufactured to be worn or held by a person for protection against one or more risks for his or her health or safety that is placed on the market separately or combined with personal non-protective equipment;
Amendment 189 #
Proposal for a regulation
Article 3 – paragraph 1 – point 6 a (new)
Article 3 – paragraph 1 – point 6 a (new)
6a. 'end user' means the person who wears or uses the PPE;
Amendment 195 #
Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 1
Article 7 – paragraph 2 – subparagraph 1
2. At trade fairs, exhibitions, and demonstrations and similar events, Member States shall not prevent the showing of PPE which does not comply with this Regulation provided that a visible sign clearly indicates that the PPE does not comply with this Regulation and is not available on the market until it has been brought into conformity.
Amendment 199 #
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 2
Article 8 – paragraph 2 – subparagraph 2
The designmanufacturer of a basic model of made-to- measure PPE shall draw up the technical documentation referred to in Annex III and carry out the EU type- examination set out in Annex V or have them carried out.
Amendment 200 #
Proposal for a regulation
Article 8 – paragraph 6
Article 8 – paragraph 6
6. Manufacturers shall indicate, on the PPE, their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the PPE. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by consumers and other end-users and market surveillance authorities.
Amendment 201 #
Proposal for a regulation
Article 8 – paragraph 7
Article 8 – paragraph 7
7. Manufacturers shall ensure that the PPE is accompanied by the instructions set out in point 1.4 of Annex II in a language which can be easily understood by consumers and other end- users, as determined by the Member State concerned.
Amendment 202 #
Proposal for a regulation
Article 8 – paragraph 7
Article 8 – paragraph 7
7. Manufacturers shall ensure that the PPE is accompanied by the instructions and other information set out in point 1.4 of Annex II in a language which can be easily understood by end- users, as determined by the Member State concerned.
Amendment 207 #
Proposal for a regulation
Article 8 – paragraph 10
Article 8 – paragraph 10
10. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary, in paper or electronic form, to demonstrate the conformity of the PPE, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by PPE which they have placed on the market.
Amendment 209 #
Proposal for a regulation
Article 9 – paragraph 2 – point b
Article 9 – paragraph 2 – point b
b) further to a reasoned request from a national market surveillancecompetent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the PPEan explosive;
Amendment 211 #
Proposal for a regulation
Article 9 – paragraph 2 – point c
Article 9 – paragraph 2 – point c
c) cooperate with the national market surveillancecompetent national authorities, at their request, on any action taken to eliminate the risks posed by PPE covered by the authorised representative's mandate.
Amendment 212 #
Proposal for a regulation
Article 10 – paragraph 2 – subparagraph 1
Article 10 – paragraph 2 – subparagraph 1
2. Before placing PPE on the market, importers shall ensure that the appropriate conformity assessment procedure(s) referred to in Article 18 have been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the PPE bears the CE marking, is accompanied by the EU declaration of conformity or a simplified EU declaration of conformity, and that it is accompanied by the instructions referred to in Article 8(7)requisite documents and that the manufacturer has complied with the requirements set out in Article 8(5) and (6).
Amendment 214 #
Proposal for a regulation
Article 10 – paragraph 4
Article 10 – paragraph 4
4. Importers shall ensure that the PPE is accompanied by the instructions and other information referred to in point 1.4 of Annex II in a language which can be easily understood by consumers and other end- users, as determined by the Member State concerned.
Amendment 222 #
Proposal for a regulation
Article 11 – paragraph 2 – subparagraph 1
Article 11 – paragraph 2 – subparagraph 1
2. Before making PPE available on the market, distributors shall verify that it bears the CE marking, is accompanied by the EU declaration of conformity or a simplified EU declaration of conformity, and that it is accompanied by the instructions and other information set out in point 1.4 of Annex II in a language which can be easily understood by end- users in the Member State in which PPE is to be made available on the market and that the manufacturer and the importer have complied with the requirements set out in Article 8(5) and (6) and Article 10(3).
Amendment 225 #
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
An importer or distributor shall be considered a manufacturer for the purposes of this Regulation and he shall be subject to the obligations of the manufacturer set out in Article 8 where he places PPE on the market under his name or trademark or modifies PPE already placed on the market in such a way that the conformity with the applicable essential health and safety requirements set out in Annex IIcompliance with this Regulation may be affected.
Amendment 227 #
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. The CE marking shall be affixed visibly, legibly and indelibly to the PPE. Where that is not possible or not warranted on account of the nature of the PPE, it shall be affixed visibly, legibly and indelibly to the packaging and to the accompanying documents.
Amendment 228 #
Proposal for a regulation
Article 23 – paragraph 2
Article 23 – paragraph 2
2. A conformity assessment body shall be established under the national law of each Member State and have legal personality.
Amendment 229 #
Proposal for a regulation
Article 23 – paragraph 4 – subparagraph 2
Article 23 – paragraph 4 – subparagraph 2
A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly or indirectly involved in the design, manufacture, making available, marketing, use or maintenance of PPE, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.
Amendment 231 #
Proposal for a regulation
Article 23 – paragraph 9
Article 23 – paragraph 9
Amendment 243 #
Proposal for a regulation
Annex II – part 1 – point 1.4 – heading
Annex II – part 1 – point 1.4 – heading
1.4. Manufacturer's instructions and information
Amendment 244 #
Proposal for a regulation
Annex II – part 1 – point 1.4 – paragraph 1 – point e
Annex II – part 1 – point 1.4 – paragraph 1 – point e
e) where applicable, the date or period of obsolescence of the PPE or of certain of its components;