2014/0108(COD) | [ParlTrack]

Proposal for a regulation
Recital 9

(9) Some products on the market that provide a protective function to the user are excluded from the scope of Directive 89/686/EEC. In order to ensure as high level of protection for the user of those products as for the PPE covered by Directive 89/686/EEC, the scope of this Regulation should include PPE for private use ~~against damp, water and heat (e.g. dish-washing gloves, oven gloves), in line with similar PPE for professional use which is already covered by Directive 89/686/EEC~~only if they are supposed to be understood as potentially life-saving by the consumer, or products intended to be used by children. Artisanal products, such as handmade gloves, for which the manufacturer does not explicitly claim a protective function are not personal protective equipment either; they are therefore not concerned by this inclusion. It is also appropriate to clarify the exclusion list set out in Annex I to Directive 89/686/EEC by adding a reference to products covered by other legislation and/or European harmonised standards and therefore are excluded from the PPE Regulation.

Amendment 148 #

Proposal for a regulation
Recital 9

(9) Some products on the market that provide a protective function to the user are excluded from the scope of Directive 89/686/EEC. In order to ensure as high level of protection ~~for the user of those products as for the PPE covered by Directive 89/686/EEC~~, the scope of this Regulation should include ~~PPE~~products for private use ~~against damp, water and heat (e.g. dish-washing gloves, oven gloves), in line with similar PPE for professional use which is already covered by Directive 89/686/EEC. Artisanal products, such as h~~to protect against heat, as well as products with reflective or fluorescent components, the main functions of which are protective and which are explicitly described and ma~~de gloves, for which~~rketed accordingly by their manufacturer does not explicitly claim a protective function are not personal protective equipment; they are therefore not concerned by this inclusion. It is also appropriate to clarify the exclusion list set out in Annex I to Directive 89/686/EEC by adding a reference to products covered by other legislation and therefore are excluded from the PPEs. Products of a decorative nature or for private use to protect against harmless atmospheric conditions, damp, water or cleaning materials of weak action are not PPE and should not therefore fall within the scope of the Regulation.

Amendment 149 #

Proposal for a regulation
Recital 9 a (new)

~~(For the definition of ‘sport’ see footnote no 2 to the Commission’s 2007 white paper on~~(9a) Equipment in the form of clothing made from bright, shiny, reflective or fluorescent materials, which is designated by its manufacturer for sports use, is recognised by its users as being for sport and is used only in that context, should not be included in the list of PPE in Annex II, point 2.13, because it is intended primarily not to protect against risks within the meaning of Article 3(1)(a) in association with Annex I but merely to assist its users in practising their sport. (The author of this amendment has decided, following talks with the Federation of the European Sporting Goods Industry (FESI) and Nike, to insert her own explanatory justification here.) Or. de sport.)

Amendment 150 #

Proposal for a regulation
Recital 9 a (new)

(9a) Products intended for private use to protect against atmospheric conditions that are not of an extreme nature should include items such as seasonal clothing and umbrellas. Products intended for private use to protect against damp and water should include items such as dishwashing gloves. Products intended for private use to protect against heat, for which the economic operator does not claim a protective function, should include items such as decorative oven gloves.

Amendment 151 #

Proposal for a regulation
Recital 14

(14) It is necessary to ensure that PPE entering the Union market complies with this Regulation and, in particular, that appropriate conformity assessment procedures have been carried out by manufacturers. Provision should therefore be made ~~for importers to make sure that the PPE they~~to the effect that importers shall place on the market only PPE which 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~~does not 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 market surveillance authorities.

Amendment 152 #

Proposal for a regulation
Recital 14

(14) It is necessary to ensure that PPE entering the Union market complies with this Regulation, with European harmonised standards 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 market surveillance authorities.

Amendment 153 #

Proposal for a regulation
Recital 16

(16) When placing PPE on the market, importers should indicate on the product their name and the address at which they can be contacted. Exceptions should be provided for in cases where the size or nature of the PPE does not allow for such an indication. This includes cases where the importer would have to open the packaging to put his name and address on the productor its cover their e-mail address at which they can be contacted.

Amendment 154 #

Proposal for a regulation
Recital 20 a (new)

(20a) 'Field test' means a trial period by the user of non-compliant PPE, before it is placed on market and for which all the necessary information of tests carried out by accredited or authorised laboratories is available in the technical file to ensure the protection of the user and meets the applicable requirements in Annex II, is made available in a very limited number for a limited time and whose principal purpose is to undertake a final evaluation of its non-protection characteristics.

Amendment 155 #

Marc TARABELLA

Proposal for a regulation
Recital 22

(22) The requirement in other internal market legislation to supply an EU declaration of conformity with the equipment has been found to facilitate and to enhance the efficiency of market surveillance and should therefore also be introduced into this Regulation. It should be possible to provide a simplified EU declaration of conformity in order to reduce the burden associated with this requirement without reduction of its effectiveness. Both possibilities should therefore be provided for in this RegulationMarket surveillance authorities should have easy access to the declaration of conformity. In order to fulfil that requirement, manufacturers should ensure the PPE is accompanied by a full copy of the declaration of conformity and the internet address at which the EU declaration of conformity can be accessed. The manufacturer should also be able to choose to provide a simplified declaration of conformity.

Amendment 156 #

Proposal for a regulation
Recital 23

(23) In order to increase the efficiency of market surveillance it is necessary to extend the obligation to draw up a complete technical documentation to all PPE characterised as having a "protective function".

Amendment 157 #

Proposal for a regulation
Recital 24

(24) ~~In order to ensure that PPE is~~PPE should be examined on the basis of the state of the art ~~the limit~~. The minimum period of validity of the EU type- examination certificate should ~~set to a maximum of~~be five years~~. A~~ and a process for reviewing the certificate should be provided for. A minimum content of the certificate should be required in order to facilitate the work of the market surveillance authorities.

Amendment 158 #

Marc TARABELLA

Proposal for a regulation
Recital 24

(24) In order to ensure that PPE is examined on the basis of the state of the art and to boost consumer confidence, the limit of validity of the EU type- examination certificate should set to a maximum of ~~five~~10 years. A process for reviewing the certificate should be provided for. A minimum content of the certificate should be required in order to facilitate the work of the market surveillance authorities.

Amendment 159 #

Proposal for a regulation
Recital 24 a (new)

(24a) The withdrawal of a harmonised standard should not invalidate existing certificates issued by notified bodies; it only concerns the conformity that is conferred onto new conformity assessments that follow the new harmonised standard. Products produced in accordance with the existing certificate should still benefit from the continuing conformity with the essential requirements and it should continue to be possible to place them on the market until the end of the validity of the relevant certificates issued by notified bodies.

Amendment 160 #

Proposal for a regulation
Recital 24 b (new)

(24b) In order to ensure that the review process takes place without placing an unnecessary burden on manufacturers, a simplified procedure should be applied for re-certification of the EU type examination certificate when the product, applied harmonised standards or other technical solutions applied by the manufacturer have not been changed and continue to meet the essential health and safety requirements in the light of the state of the art, making therefore unnecessary additional tests or technical examinations.

Amendment 161 #

Proposal for a regulation
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 protection, particularly with regard to transparency and to explaining the certification, and are not covered by Union harmonisation legislation.

Amendment 162 #

Proposal for a regulation
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 protection and are ~~not covered by Union harmonisation legislation~~in accordance with European harmonised standards.

Amendment 163 #

Proposal for a regulation
Recital 30

(30) In order to ensure a consistent level of quality in the performance of conformity assessment of PPE, it is also necessary to set requirements that notifying authorities and other bodies involved in the assessment, notification and monitoring of notified bodies must fulfil and to delimit their responsibilities clearly.

Amendment 164 #

Proposal for a regulation
Recital 31

(31) In order to take into account the progress of technical knowledge and new scientific evidence, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission to amend the ~~list of PPE included in each category~~categories of risk against which the PPE is intended to protect users and consumers, and to draw up a non-exhaustive list of products used in private households, which are not covered by this Regulation. It is of particular importance that the Commission carr~~ies~~y out appropriate and transparent consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.

Amendment 165 #

Proposal for a regulation
Recital 33

(33) Member States should lay down rules on penalties applicable to infringements of the provisions of this Regulation ~~and ensure that they are implemented~~. Those penalties should be effective, proportionate and dissuasive. The Member States’ efficient application of the penalties will be decisive with regard to their effectiveness and also of key importance in terms of the overall value of the Regulation.

Amendment 166 #

Proposal for a regulation
Article 1 – paragraph 1 a (new)

The provisions of this Regulation are based on the precautionary principle. Or. de (In accordance with Article 191(2) of the TFEU)

Amendment 167 #

Proposal for a regulation
Article 2 – paragraph 2 – point b

(b) ~~intend~~designed to be used for self-defence, other than PPE intended for self-defence in sporting activities;

Amendment 168 #

Proposal for a regulation
Article 2 – paragraph 2 – point c

Amendment 169 #

Proposal for a regulation
Article 2 – paragraph 2 – point c – point i (new)

(i) atmospheric conditions that are not of an extreme nature (including, but not limited to, seasonal clothing and umbrellas);

Amendment 170 #

Daniel DALTON

Proposal for a regulation
Article 2 – paragraph 2 – point c – point i (new)

(i) heat (gloves etc.) for which the economic operator does not explicitly claim a protective function against short- term exposure to dangerous heat;

Amendment 171 #

Proposal for a regulation
Article 2 – paragraph 2 – point c – point ii (new)

(ii) damp and water not of an extreme nature (including, but not limited to, dish- washing gloves);

Amendment 172 #

Proposal for a regulation
Article 2 – paragraph 2 – point c – point iii (new)

(iii) heat (including, but not limited to, gloves) for which the economic operator does not explicitly claim a protective function against extreme heat;

Amendment 173 #

Proposal for a regulation
Article 2 – paragraph 2 – point c a (new)

(ca) intended for protection, in private households, against damp, water or cleaning materials of weak action;

Amendment 174 #

Proposal for a regulation
Article 2 – paragraph 2 – point c b (new)

(cb) intended for protection, in private households, against heat, and not explicitly described and marketed by their manufacturer as having this protective function;

Amendment 175 #

Proposal for a regulation
Article 2 – paragraph 2 – point c c (new)

(cc) intended for private use and decorative in nature or containing reflective or fluorescent elements and not specifically designated or advertised by the manufacture as having a protective function;

Amendment 176 #

Proposal for a regulation
Article 2 – paragraph 1 – point e a (new)

(ea) in the form of clothing, with reflective or fluorescent garments that do not completely encircle a part of the body (arm, leg or chest) and for which the economic operator does not explicitly claim a protective function against one or more risks to the user´s health or safety;

Amendment 177 #

Proposal for a regulation
Article 2 – paragraph 2 – point e a (new)

(ea) in the form of clothing, with reflective or fluorescent garments that do not completely encircle a part of the body (arm, leg, or chest), which are included for reasons of fashion and for which the economic operator does not explicitly claim a protective function against one or more risks to the user's health or safety;

Amendment 178 #

Proposal for a regulation
Article 3 – paragraph 1 – point 1 – point a

(a) equipment intended to be worn or held by a person for protection against one or more risks for his or her health or safety and therefore marked as having a "protective function", that is placed on the market separately or combined with personal non-protective equipment;

Amendment 179 #

Proposal for a regulation
Article 3 – paragraph 1 – point 1 – point c

(c) connexion systems for equipment referred to in point (a) that are not held or worn by a person, that are ~~intend~~designed to connect that equipment to an external device or ~~structure, that are removable and not intended to be permanently fixed to a structur~~to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use;

Amendment 180 #

Proposal for a regulation
Article 3 – paragraph 1 – point 2

2. 'individually adapted PPE' means PPE produced in series where each item is, after manufacture~~d to fit an~~ for its intended purpose, can be adapted to the needs of individual users;

Amendment 181 #

Proposal for a regulation
Article 3 – paragraph 1 – point 3 a (new)

3a.'PPE type ': sample of complete PPE used as a model for a PPE series that is described in the technical documentation in accordance with Annex III and has - in the case of category II or III - undergone the EU type-examination procedure in accordance with Annex I;

Amendment 182 #

Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 1

At trade fairs, exhibitions, ~~and~~ demonstrations or field tests, 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~~and is not available on the market. Field tests shall not be does ~~not comply with this Regulation and is not availabl~~igned to test the protection performance of the PPE, but to evaluate on the ~~market until it has been brought into~~r non-protective aspects such as conmfor~~mity~~t, ergonomics and design.

Amendment 183 #

Ildikó GÁLL-PELCZ

Proposal for a regulation
Article 8 – paragraph 3

3. Manufacturers shall keep the technical documentation and the EU declaration of conformity for at least 10five years after the PPE has been placed on the market.

Amendment 184 #

Proposal for a regulation
Article 8 – paragraph 4

4. Manufacturers shall ensure that procedures are in place for series production to remain in conformity with this Regulation. Changes in the design or characteristics of the PPE and changes in the harmonised standards or in other technical specifications by reference to which the conformity of the PPE is declared shall be adequately taken into account. and accordingly attest it by the EU declaration of conformity. 4a. Changes in the harmonised standards or in other technical specifications as regards the EHSR and changes in Annexes I or II to this Regulation shall be adequately taken into account by either repeating or updating or integrating the conformity assessment procedures as provided for in Article 18. 4b. Changes in the harmonised standards or in other technical specifications not in relation with the EHSR shall be adequately taken into account by the manufacturers, which may decide to either repeat, update or integrate the conformity assessment procedures as provided for in Article 18. 4c. Changes by the manufacturer in the design or characteristics of the PPE that affect the compliance with EHSR shall be adequately taken into account by either repeating or updating or integrating the conformity assessment procedures as provided for in Article 18. 4d. With regard to PPE of categories II and III, manufacturers that intend to change the design or characteristics of the PPE without impact to the compliance with EHSR shall inform and obtain authorisation from the notified body.

Amendment 185 #

Proposal for a regulation
Article 8 – paragraph 5

5. Manufacturers shall ensure that the PPE which they place on the market bears either a type, batch or serial number or other element allowing its identification or, where the size or nature of the PPE does not allow it, that the required information is provided on the packaging or a document accompanying the PPE.

Amendment 186 #

Proposal for a regulation
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 athe language ~~easily understood by end-users and market surveillance authorities~~or languages of the Member State in which the product is to be marketed.

Amendment 187 #

Proposal for a regulation
Article 8 – paragraph 6

6. Manufacturers shall indicate~~, on the PPE,~~ their name, registered trade name or registered trade mark ~~and~~, the postal or e-mail address at which they can be contacted o~~r, where that is not possible, on~~n the PPE, 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 end-users and market surveillance authorities.

Amendment 188 #

Proposal for a regulation
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 end-users and market surveillance authorities~~the official language or languages of the Member States(s) in which the PPE is to be marketed.

Amendment 189 #

Proposal for a regulation
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 end-users, as determined by the Member State concerned.deleted

Amendment 190 #

Proposal for a regulation
Article 8 – paragraph 7 – subparagraph 1 a (new)

Manufacturers shall have the possibility to provide manufacturers´ instructions, labelling or marking by pictograms on the PPE or, where the size or nature of the PPE does not allow it, on the packaging or a document accompanying the PPE.

Amendment 191 #

Proposal for a regulation
Article 8 – paragraph 7 a (new)

7a. Manufacturers shall ensure that performance as recorded during relevant technical tests to check the levels of classes of protection provided by the PPE is available electronically or upon request.

Amendment 192 #

Proposal for a regulation
Article 8 – paragraph 9

9. Manufacturers who consider or have reason to believe that PPE which they have placed on the market is not in conformity with this Regulation shall immediately take the necessary corrective measures to bring it into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the PPE presents a risk, manufacturers shall immediately inform the market surveillance authorities of the Member States in which they made the PPE available on the market and, where necessary, in a suitable manner, consumers who might be endangered by the product non-conformity to that effect, giving details, in particular, of the non- conformity and of any corrective measures taken.

Amendment 193 #

Proposal for a regulation
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 to demonstrate the conformity of the PPE, in paper or electronic form, 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 194 #

Proposal for a regulation
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 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 195 #

Proposal for a regulation
Article 10 – paragraph 3

3. Importers shall indicate~~, on the PPE, their name, registered trade name or registered trade mark and the posta~~ their name, postal or e-mail address at which they can be contacted, o~~r where that is not possible, on~~n the PPE, its packaging or in a document accompanying the PPE. Importers shall indicate the registered trade name or registered trade mark if different from that of the manufacturer . The contact details shall be in a language easily understood by end-users and market surveillance authorities.

Amendment 196 #

Proposal for a regulation
Article 10 – paragraph 3

3. Importers 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 contact details shall be in ~~a language easily understood by end-users and market surveillance authorities~~the official language or languages of the Member State(s) in which the PPE is to be marketed.

Amendment 197 #

Proposal for a regulation
Article 10 – paragraph 6

6. Importers who consider or have reason to believe that PPE which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring the PPE into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the PPE presents a risk, importers shall immediately inform the market surveillance authorities of the Member States in which they made the PPE available on the market and, where necessary, in a suitable manner, consumers who might be endangered by the product non-conformity to that effect, giving details, in particular, of the non- conformity and of any corrective measures taken.

Amendment 198 #

Proposal for a regulation
Article 10 – paragraph 7

7. Importers shall, for at least 10 years after the PPE has been placed on the market, ~~keep~~ensure that a copy of the EU declaration of conformity a~~t the disposal of the market surveillance authorities and ensure that~~ nd the technical documentation can be made available to those market surveillance authorities, upon request.

Amendment 199 #

Proposal for a regulation
Article 10 – paragraph 7

7. Importers shall, for at least 10 years after the PPE has been placed on the market, keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request. After five years, it shall be sufficient to keep a declaration of conformity in electronic form.

Amendment 200 #

Proposal for a regulation
Article 10 – paragraph 8

8. Importers shall, further to a ~~reasoned~~ request from a competent national authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of 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 201 #

Proposal for a regulation
Article 10 – paragraph 8

Amendment 202 #

Proposal for a regulation
Article 11 – paragraph 2 – subparagraph 1

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 set out in point 1.4 of Annex II in a language which can be easily understood byrequired documents in an official language of the EU representing 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 203 #

Proposal for a regulation
Article 11 – paragraph 4

4. Distributors who consider or have reason to believe that PPE which they have made available on the market is not in conformity with the requirements of this Regulation shall make sure that the necessary corrective measures are taken to bring it into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the PPE presents a risk, distributors shall immediately inform the market surveillance authorities of the Member States in which they have made the PPE available on the market and, if necessary, and in an appropriate manner, the consumers who could be placed at risk by virtue of the non-conformity of the product, to that effect, giving details, in particular, of the non- conformity and of any corrective measures taken.

Amendment 204 #

Proposal for a regulation
Article 11 – paragraph 5

5. Distributors shall, further to a ~~reasoned~~ request from a competent national authority, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of the PPE. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by PPE which they have made available on the market.

Amendment 205 #

Proposal for a regulation
Article 11 – paragraph 5

Amendment 206 #

Proposal for a regulation
Article 14 – paragraph 1 a (new)

Unless otherwise provided for by legislation, the withdrawal of a harmonised standard shall not invalidate existing certificates issued by notified bodies, it shall only concern the conformity that is conferred onto new conformity assessments that follow the new harmonised standard. Products produced in accordance with the existing certificate shall still benefit from continuing conformity with the essential requirements and may continue to be placed on the market until the end of the validity of the relevant certificates issued by notified bodies.

Amendment 207 #

Proposal for a regulation
Article 16 – paragraph 4

4. For category III PPE, the CE marking shall be followed by the identification number of the notified body involved in the procedure for ensuring conformity to type based on product verification or the procedure for ensuring conformity to type based on quality assurance of the production process. The identification number of the notified body shall be affixed by the manufacturer or his authorised representative after having received permission and instructions from the notified body to do so.

Amendment 208 #

Proposal for a regulation
Article 16 – paragraph 4

4. For category III PPE, the CE marking shall be followed by the identification number of the notified body involved in the procedure for ensuring conformity to type based on product verification or the procedure for ensuring conformity to type based on quality assurance of the production process. The identification number of the notified body shall be affixed under its instructions, by the manufacturer or his authorised representative.

Amendment 209 #

Proposal for a regulation
Article 23 – paragraph 11

11. Conformity assessment bodies shall participate in, or ensure that their personnel responsible for carrying out the conformity assessment tasks are informed of, the relevant standardisation activities and the activities of the notified body coordination group established under Article 35 of this Regulation and shall apply ~~as general guidance the administrativ~~the decisions and documents produced as a result of the work of that group.

Amendment 210 #

Proposal for a regulation
Article 26 – paragraph 2

2. The application for notification shall be accompanied by a description of the conformity assessment activities, the conformity assessment procedure(s) and the kinds of PPE for which that body claims to be competent, as well as by an accreditation certificate~~, where one exists,~~ issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 23.

Amendment 211 #

Proposal for a regulation
Article 26 – paragraph 3

3. Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 23.deleted

Amendment 212 #

Proposal for a regulation
Article 27 – paragraph 4

4. Where a notification is not based on an accreditation certificate referred to in Article 26(2), the notifying authority shall provide the Commission and the other Member States with documentary evidence which attests to the conformity assessment body's competence and the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article 23.deleted

Amendment 213 #

Marc TARABELLA

Proposal for a regulation
Article 32 – paragraph 1

Member States shall ensure that an EU- wide appeal procedure against decisions of ~~the~~ notified bodies is available.

Amendment 214 #

Proposal for a regulation
Article 35 – paragraph 2

~~Member States shall ensure that the bodies notified by them~~Notified bodies shall participate in the work of that group, directly or by means of designated representatives. In the event that a notified body does not comply with this requirement, the notification shall be suspended or withdrawn.

Amendment 215 #

Proposal for a regulation
Article 36 – paragraph 1 a (new)

The Commission shall be empowered to adopt, in response to technical progress and new knowledge or scientific evidence, delegated acts in accordance with Article 37 on the drawing-up of a non-exhaustive list of products covered by Article 2(2)(c) to (cc) inclusive.

Amendment 216 #

Proposal for a regulation
Article 39 – paragraph 1

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 dissuasive. Member States shall notify those provisions to the Commission by [3 months prior to the date of application of this Regulation] at the latest and shall notify it without delay of any subsequent amendment affecting themThey must also reflect the seriousness, the duration and, if possible, the nature of the infringement and the issue of whether or not the economic operator in question has perpetrated a similar infringement in the recent past. Member States shall notify those provisions to the Commission by [3 months prior to the date of application of this Regulation] at the latest and shall notify it without delay of any subsequent amendment affecting them. Member States shall notify the Commission of the nature and severity of the penalties imposed under this Regulation on their territory and of the identity of the recipient of each penalty. The Commission shall publish this notification immediately.

Amendment 217 #

Proposal for a regulation
Annex I – section 1 – paragraph 1 – point b

~~(b) contact with water or cleaning materials of weak action;~~deleted

Amendment 218 #

Proposal for a regulation
Annex I – section 1 – paragraph 1 – point b

(b) contact with ~~water or~~ cleaning materials of weak action or prolonged contact with water;

Amendment 219 #

Proposal for a regulation
Annex I – section 2 – paragraph 1 – point b

~~(b) made-to-measure PPE except where such PPE is intended to protect users against risks listed in Category I.~~deleted

Amendment 220 #

Proposal for a regulation
Annex I – section 3 – paragraph 1 – point a

(a) ~~inhalation of harmful substanc~~health hazardous substances, chemicals and mixtures;

Amendment 221 #

Proposal for a regulation
Annex I – section 3 – paragraph 1 – point b

(b) ~~aggressive chemical~~harmful biological agents;

Amendment 222 #

Proposal for a regulation
Annex I – section 3 – paragraph 1 – point l a (new)

(la) occupational risk of severe impact to the head.

Amendment 223 #

Proposal for a regulation
Annex II – part 1 – point 1.3 – point 1.3.3 – paragraph 1

If the same manufacturer places on the market several models of PPE ~~models~~ of different types in order to ensure the simultaneous protection of adjacent parts of the body, they must be compatible.

Amendment 224 #

Proposal for a regulation
Annex II – part 1 – point 1.3 – point 1.3.3 a (new)

1.3.3 a. Protective clothing containing removable protectors Protective clothing containing removable protectors constitute PPE and should be assessed as a combination during conformity assessment procedures.

Amendment 225 #

Proposal for a regulation
Annex II – part 1 – point 1.4 – introductory part

1.4. Manufacturer's instructions and information

Amendment 226 #

Proposal for a regulation
Annex II – part 1 – point 1.4 – paragraph 1 – point b

~~(b) performance as recorded during technical tests to check the levels or classes of protection provided by the PPE;~~deleted

Amendment 227 #

Proposal for a regulation
Annex II – part 1 – point 1.4 – paragraph 1 – subparagraph 1

These instructions, which must be precise and comprehensible and clearly legible, must be provided at least in the official language(s) of the Member State of destination. The instructions shall be deemed to be clearly legible if they can be read easily from an appropriate distance and without artificial aids by a normal user with normal vision.

Amendment 228 #

Proposal for a regulation
Annex II – part 2 – point 2.2 – paragraph 1

As far as possible, PPE enclosing the parts of the body to be protected must be ~~sufficiently ventilat~~designed to limit perspiration resulting from use; otherwise, ~~it must be equipped with~~ means of absorbing perspiration must be incorporated.

Amendment 229 #

Proposal for a regulation
Annex II – part 2 – point 2.9 – paragraph 1

Where PPE incorporates components which can be adjusted or removed by the user for replacement purposes, they must be designed and manufactured so that they can be easily attached, adjusted and removed without tools.

Amendment 230 #

Proposal for a regulation
Annex II – part 2 – point 2.12 – paragraph 1

The identification markings or indicators directly or indirectly relating to health and safety affixed to these types of PPE must, if possible, take the form of harmonized pictograms or ideograms. They must be perfectly visible and legible and remain so throughout the foreseeable useful life of the PPE. In addition, these markings must be complete, precise and comprehensible so as to prevent any misinterpretation; in particular, when such markings include words or sentences, the latter must be written in the official language(s) of the Member State ~~where the equipment is to be used.~~of destination of the PPE;

Amendment 231 #

Ildikó GÁLL-PELCZ

Proposal for a regulation
Annex II – part 2 – point 2.12 – paragraph 1

The identification markings or indicators directly or indirectly relating to health and safety affixed to these types of PPE must, if possible, take the form of harmonized pictograms or ideograms. They must be perfectly visible and legible and remain so throughout the foreseeable useful life of the PPE. In addition, these markings must be complete, precise and comprehensible so as to prevent any misinterpretation; in particular, when such markings include words or sentences, the latter must be written in the official language(s) of the Member State ~~where the~~on whose market the individual equipment is to be ~~used~~offered for sale.

Amendment 232 #

Proposal for a regulation
Annex II – part 3 – point 3.4 – title

3.4. Protection in ~~the water~~liquids

Amendment 233 #

Proposal for a regulation
Annex II – part 3 – point 3.4 – point 3.4.2 – paragraph 1

Clothing which will ensure an effective degree of buoyancy, depending on its foreseeable use, which is safe when worn and which affords positive support in ~~water~~liquids. In foreseeable conditions of use, this PPE must not restrict the user's freedom of movement but must enable him, in particular, to swim or take action to escape from danger or to rescue other persons.

Amendment 234 #

Proposal for a regulation
Annex V – section 1 – point 6 – point 6.2 – point i

(i) the date of issue and, where appropriate, the date of expiry or the date(s) of renewal;

Amendment 235 #

Proposal for a regulation
Annex V – section 1 – point 6 – point 6.2 – point j

~~(j) the date of expiry (a maximum of five years after the date of issue or the date of the last renewal);~~deleted

Amendment 236 #

Proposal for a regulation
Annex V – section 1 – point 6 – point 6.2 – point j

(j) the date of expiry (a maximum of five years after the date of issue or the date of the last renewal) where appropriate;

Amendment 237 #

Proposal for a regulation
Annex V – section 1 – point 7 – point 7.1 a (new)

7.1a. At the earliest five years after the date of issue or the last date of renewal, and if changes to the acknowledged state of the art suggest that the approved type no longer meets key health and safety requirements, the notified body shall decide whether the type in question should undergo a fresh EU type-approval procedure.

Amendment 238 #

Proposal for a regulation
Annex V – section 1 – point 7 – point 7.6 a (new)

7.6.a When the product, harmonised standards or other technical solutions applied by the manufacturer have not been changed and continue to meet the essential health and safety requirements, in light of the state of the art standards, a simplified procedure shall be applied for automatic re-certification therefore making additional tests or technical examinations unnecessary.

source: 549.462

2015/03/04 EMPL 117 amendments...

Amendment 136 #

Proposal for a regulation
Recital -1 (new)

(-1) The right to health and safety is a fundamental right and all workers enjoy a legal guarantee of working conditions which respect their health, safety and dignity. Considering that the cost to enterprises and social security systems of occupational accidents and diseases is estimated at 5,9 % of GDP and that adequate worker prevention promotes wellbeing, quality of work and productivity, risk prevention, in particular through the use of quality personal protective equipment, is essential to reducing the rate of work-related accidents and sickness.

Amendment 137 #

Proposal for a regulation
Recital 3

(3) However, experience with its application has shown inadequacies and inconsistencies in the product coverage and conformity assessment procedures. In order to take account of this experience and to provide clarification in relation to the framework within which products covered by this Regulation may be marketed, certain aspects of Directive 89/686/EEC should be revised and enhanced while maintaining the overarching principle of health and safety protection.

Amendment 138 #

Proposal for a regulation
Recital 3 a (new)

(3a) This Regulation should apply to all forms of supply, including distance selling.

Amendment 139 #

Proposal for a regulation
Recital 4

(4) Since the scope, the ~~essential~~ health and safety requirements and conformity assessment procedures are to be identical in all the Member States there is almost no flexibility in transposing Directives based on the New Approach principles into national law. Directive 89/686/EEC should therefore be replaced by a Regulation, which is the appropriate legal instrument for imposing clear and detailed rules which do not give room for divergent transposition by Member States. with a view, in particular, to safeguarding public health, improving safety at work, and ensuring user protection.

Amendment 140 #

Proposal for a regulation
Recital 4

(4) Since the scope, the essential health and safety requirements and conformity assessment procedures are to be identical in all the Member States there is almost no flexibility in transposing Directives based on the New Approach principles into national law. Directive 89/686/EEC should therefore be replaced by a Regulation, which is the appropriate legal instrument for imposing clear and detailed rules which do not give room for divergent transposition by Member States this should be done by applying a clear and target- based approach with the aim of improving safety at work and ensuring user protection.

Amendment 141 #

Proposal for a regulation
Recital 9

(9) Some products on the market that provide a protective function to the user are excluded from the scope of Directive 89/686/EEC where they are only intended for private use. In order to ~~ensur~~provide as high level of protection ~~for the user of those products as for the PPE covered by Directive 89/686/EEC, the scope of this Regulation~~, items for protecting the hands against extreme heat in a domestic environment should be include ~~PPE for private use against damp, water and heat (e.g. dish-washing gloves, oven gloves), in line with similar PPE for professional use which is already covered by Directive 89/686/EEC~~d within the scope of this Regulation if they specifically make a protective claim. Artisanal products, such as handmade gloves and oven gloves, for which the manufacturer does not explicitly claim a protective function are not personal protective equipment; they ~~are~~should therefore not concerned by this inclusion. It is also appropriate to clarify the exclusion list set out in Annex I to Directive 89/686/EEC by adding a reference to products covered by other legislation and therefore are excluded from the PPE Regulationbe included in the scope of this Regulation. Instead, self-certification should be encouraged for those products. Many manufacturers are already doing this today.

Amendment 142 #

Proposal for a regulation
Recital 9

(9) Some products on the market that provide a protective function to the user are excluded from the scope of Directive 89/686/EEC. Any such exclusion should only be allowed if an equivalent level of health and safety protection to this Regulation or Directive 89/3921/EC is provided for. In order to ensure as high level of protection for the user of those products as for the PPE covered by Directive 89/686/EEC, the scope of this Regulation should include PPE for private use against damp, water and heat (e.g. dish-washing gloves, oven gloves), in line with similar PPE for professional use which is already covered by Directive 89/686/EEC. Artisanal products, such as handmade gloves, for which the manufacturer does not explicitly claim a protective function are not personal protective equipment; they are therefore not concerned by this inclusion. It is also appropriate to clarify the exclusion list set out in Annex I to Directive 89/686/EEC by adding a reference to products covered by other legislation and therefore are excluded from the PPE Regulation.

Amendment 143 #

Proposal for a regulation
Recital 10

Amendment 144 #

Proposal for a regulation
Recital 10

(10) In order to facilitate the understanding and uniform application of this Regulation, new definitions for ‘individually adapted PPE’ and ‘made-to-measure PPE’ should be introduced including clear definitions of the end-user of PPE and the conformity assessment procedures for these kinds of PPE should be adapted to the specific conditions of their manufacture. In the definition of "individually adapted PPE" and "made-to-measure PE" it should be clearly stated that the individualisation of PPE must have a material impact on the working environment and safety at work.

Amendment 145 #

Proposal for a regulation
Recital 10 a (new)

(10a) During field demonstrations and field tests, adequate measures should be taken to ensure the protection of persons. Field tests should not be designed to test the protection performance of the PPE but to evaluate other non-protective aspects such as comfort, ergonomics and design. All concerned parties, for instance the employer as well as the wearer or the consumer, should be informed in advance concerning the scope and purpose of the test.

Amendment 146 #

Proposal for a regulation
Recital 11

(11) Economic operators should be responsible for the compliance of products, in relation to their respective roles in the whole supply chain, so as to ensure a high level of protection of public interests, such as health and safety, and the proper information and protection of users and to guarantee fair competition on the Union market.

Amendment 147 #

Proposal for a regulation
Recital 11

(11) Economic operators should be responsible for the compliance of ~~products~~the PPE, 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, where appropriate, other persons, to guarantee fair competition on the Union market.

Amendment 148 #

Proposal for a regulation
Recital 11

(11) Economic operators should be responsible for the compliance of ~~products~~PPE, 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 149 #

Proposal for a regulation
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 ~~products which compl~~PPE which is in conformity with this Regulation. This Regulation should provide a clear and proportionate distribution of obligations which correspond to the role of each economic operator in the supply and distribution chain.

Amendment 150 #

Proposal for a regulation
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 ~~products~~PPE 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)

(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

(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 ~~marke~~competent surveillance authorities.

Amendment 153 #

Proposal for a regulation
Recital 16

(16) When placing PPE on the market, importers should indicate on the product their name and the address at which they can be contacted as well as indications of webpages on which the end-user of the PPE can access additional information on how to correctly use the PPE. Exceptions should be provided for in cases where the size or nature of the PPE does not allow for such an indication. This includes cases where the importer would have to open the packaging to put his name and address on the product.

Amendment 154 #

Proposal for a regulation
Recital 17

(17) Any economic operator that either places PPE on the market under its own name or trademark or modifies a product in such a way that compliance with the requirements of this Regulation may be affected is~~hould be~~ considered to be the manufacturer and should assume the obligations of the manufacturer.

Amendment 155 #

Proposal for a regulation
Recital 17

(17) Any economic operator that either places PPE on the market under its own name or trademark or modifies ~~a product~~PPE 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 156 #

Proposal for a regulation
Recital 18

(18) Distributors and importers, being close to the market place, should only be involved in market surveillance tasks carried out by competent national authorities when any conflict of interest can be avoided, and should be prepared to participate actively, providing those authorities with all necessary information relating to the PPE concerned.

Amendment 157 #

Proposal for a regulation
Recital 18

(18) Distributors and importers, being close to the market place, should be involved in market surveillance tasks carried out by competent national authorities, and ~~should~~must be prepared to participate actively, providing those authorities with all necessary information relating to the PPE concerned.

Amendment 158 #

Jérôme LAVRILLEUX

Proposal for a regulation
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 product available on the market and to determine precisely, clearly and transparently the share of responsibility borne by each operator.

Amendment 159 #

Proposal for a regulation
Recital 19

(19) Ensuring traceability of PPE throughout the whole 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 product available on the market.

Amendment 160 #

Proposal for a regulation
Recital 19

Amendment 161 #

Proposal for a regulation
Recital 21

(21) It is necessary to clearly specify the relationship and scope of this Regulation with the entitlement of Member States to lay down requirements for the use of PPE at workplace, in particular pursuant to Council Directive 89/656/EEC19 , in order to avoid any confusion and ambiguity and hence ensure the free movement of compliant PPE. Article 4 of that Directive obliges employers to provide PPE which complies with the relevant Union provisions on design and manufacture with respect to health and safety. Pursuant to that Article, manufacturers of PPE who provide that PPE to their employees must ensure that such PPE fulfils the requirements laid down in this Regulation. __________________ 19 Council Directive 89/656/EEC of 30 November 1989 on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace (OJ L 393, 30.12.1989, p. 18).

Amendment 162 #

Proposal for a regulation
Recital 24

(24) In order to ensure that PPE is examined on the basis of the state of the art the limit of validity of the EU type- examination certificate should set to a maximum of fiseven years. A process for reviewing the certificate should be provided for. Such review should consist of a simple and expedient procedure. A minimum content of the certificate should be required in order to facilitate the work of the market surveillance authorities.

Amendment 163 #

Proposal for a regulation
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

(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 165 #

Proposal for a regulation
Recital 28

(28) In order to ensure compliance with the essential health and safety requirements laid down in this Regulation, 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 166 #

Proposal for a regulation
Recital 31

(31) In order to take into account the progress of technical knowledge and new scientific evidence, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission to amend the list of PPE included in each category. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level and consult representatives of employee and employer's organisations from sectors that habitually make use of PPE in their operations. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.

Amendment 167 #

Proposal for a regulation
Recital 31

(31) In order to take into account the progress of technical knowledge and new scientific evidence, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission to amend the list of PPE included in each category. It is of particular importance that the Commission carries out appropriate consultations and assesses the impact of its proposals during its preparatory work, including at expert level. The Commission, when preparing and drawing-up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and Council.

Amendment 168 #

Proposal for a regulation
Recital 33

(33) Member States should lay down rules on guidance, control and penalties applicable to infringements of the provisions of this Regulation and ensure that they are implemented bearing in mind that guidance is the best tool to avoid unintended mistakes by employers, manufacturers of PPE and end-users. Those penalties should be effective, proportionate and dissuasive.

Amendment 169 #

Proposal for a regulation
Recital 33

(33) Member States should lay down rules on surveillance, control, sanctions and penalties applicable to infringements of the provisions of this Regulation and ensure that they are implemented. Those penalties and sanctions should be effective, proportionate and dissuasive.

Amendment 170 #

Proposal for a regulation
Recital 33

(33) Member States should lay down rules on penalties applicable to infringements of the provisions of this Regulation and ensure that they are implemented. Those penalties should be imposed expediently, be effective, proportionate and dissuasive.

Amendment 171 #

Proposal for a regulation
Recital 33 a (new)

(33a) Member States should establish, preferably through cooperation between the surveillance authorities and the social partners, a single point of contact in which the end-users of the PPE can report flaws and errors concerning the PPE. The surveillance authorities are obliged to react to the report from the end-users in a fast and efficient manner.

Amendment 172 #

Claude ROLIN

Proposal for a regulation
Recital 33 a (new)

(33a) Directive 89/656/EEC lays down minimum requirements for personal protective equipment used by workers at work, and national provisions relating to safety at work make the use of PPE compulsory; Each Member State should therefore take suitable steps to encourage employers and workers to use appropriate PPE, including by providing employers, workers and trade unions with clear information about the compulsory nature of the use of PPE and by singling out as examples of best practice employers who apply these rules and observe general prevention principles as set out in Article 6(2) of Directive 89/391/EEC on the introduction of measures to encourage improvements in the safety and health of workers at work.

Amendment 173 #

Proposal for a regulation
Recital 35 a (new)

(35a) Special attention should be drawn to the field of undeclared work as, due to the impossibility of checking compliance with health and safety at work provisions, the conditions in the field of undeclared work allow workers to be exposed to high health risks and employers to escape liability. Domestic work, mainly performed by women, poses a particular challenge, as the work is in the informal sector, singularised and, by its nature, invisible.

Amendment 174 #

Proposal for a regulation
Recital 35 b (new)

(35b) Raising awareness about health and safety, including PPE, should be included in education curricula from an early age so as to bring down accident rates and increase health and safety; training on health and safety and PPE should be integrated especially into vocational training, fully recognised and attested by a diploma. Efforts should be made to substantially improve information and training for entrepreneurs. The results of research for new PPE, as the consequence of technology advances and new challenges, should be better disseminated.

Amendment 175 #

Proposal for a regulation
Recital 36

(36) Directive 89/686/EEC has been amended several times. Since further substantial amendments are to be made and in order to ensure ~~a uniform~~ implementation throughout the Union, Directive 89/686/EEC should be repealed and replaced by a Regulation.

Amendment 176 #

Proposal for a regulation
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 177 #

Proposal for a regulation
Article 2 – paragraph 2 – point c

Amendment 178 #

Proposal for a regulation
Article 2 – paragraph 2 – point c – point i (new)

i) atmospheric conditions that are not of an extreme nature (seasonal clothing, umbrellas etc.);

Amendment 179 #

Proposal for a regulation
Article 2 – paragraph 2 – point c – point ii (new)

ii) damp and water (dish-washing gloves etc.);

Amendment 180 #

Proposal for a regulation
Article 2 – paragraph 2 – point c – point iii (new)

iii) heat (gloves etc.) for which the economic operator does not explicitly claim a protective function against extreme heat;

Amendment 181 #

Proposal for a regulation
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 182 #

Proposal for a regulation
Article 2 – paragraph 2 – point e

(e) for head, face or eye protection of users, subject to ~~the relevant~~ Regulation 22 of the United Nations Economic Commission for Europe (UNECE), o~~f two- or three- wheeled motor vehicle~~n uniform provisions concerning the approval of protective helmets and of their visors for drivers and passengers of motor cycles and mopeds.

Amendment 183 #

Proposal for a regulation
Article 2 – paragraph 2 – subparagraph 1 a (new)

In that event, the health and safety of users shall be ensured as far as possible in the light of the objectives of this Regulation and in accordance with the European Framework Directive on Safety and Health at Work 89/391/EC.

Amendment 184 #

Proposal for a regulation
Article 3 – paragraph 1 – point 1 – point a

a) equipment ~~intend~~designed 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 185 #

Proposal for a regulation
Article 3 – paragraph 1 – point 1 – point a

(a) equipment ~~intend~~designed 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 186 #

Proposal for a regulation
Article 3 – paragraph 1 – point 1 – point c

(c) connexion systems for equipment referred to in point (a) that are not held or worn by a person, but which are essential to the equipment's function, that are intended to connect that equipment to an external device or structure, that are removable and not intended to be permanently fixed to a structure;

Amendment 187 #

Proposal for a regulation
Article 3 – paragraph 1 – point 2

2. 'individually adapted PPE' means PPE ~~produced in series~~ where each item is manufactured to fit an individual user in accordance with his or her special needs and characteristics;

Amendment 188 #

Proposal for a regulation
Article 3 – paragraph 1 – point 3

3. 'made-to-measure PPE' means PPE produced as a single unit to accommodate the special needs of an individual user according to a basic model, following the instructions of the ~~design~~manufacturer of that basic model and respecting the range of ~~permissible~~ variations;

Amendment 189 #

Proposal for a regulation
Article 3 – paragraph 1 – point 6 a (new)

6a. 'end user' means the person who wears or uses the PPE;

Amendment 190 #

Proposal for a regulation
Article 3 – paragraph 1 – point 18 a (new)

18a. 'Union harmonisation legislation' means any Union legislation harmonising the conditions for the marketing of products;

Amendment 191 #

Proposal for a regulation
Article 4 – paragraph 1

Member States shall take all appropriate and necessary measures to ensure and enforce that PPE is made available on the market only if, where properly maintained, its functioning clearly explained and used for its intended purpose, it complies with this Regulation.

Amendment 192 #

Proposal for a regulation
Article 5 – paragraph 1

PPE shall fulfil the applicable essential health and safety requirements set out in Annex II and in full compliance with Directive 89/391/EC.

Amendment 193 #

Proposal for a regulation
Article 6 – paragraph 1

This Regulation shall not affect Member States' entitlement, in particular when implementing Directive 89/656/EEC, to lay down requirements concerning the use of PPE provided that these requirements ~~do not affect the design of PPE which is placed on the market in accordance with this Regulation~~are justified by an added value in terms of health and safety of the user.

Amendment 194 #

Jutta STEINRUCK

Proposal for a regulation
Article -7 (new)

Article -7 Field tests In the context of a field test, a non- certified PPE may be handed over in limited quantities and for a maximum period of six months for testing or validation purposes. Prior to the start of the test, the manufacturer shall lay down the duration and purpose of the testing, and state the reasons why testing is required, and shall have these details confirmed by the parties concerned. Field tests of this kind shall be carried out only in non-dangerous situations and shall be performed to evaluate, inter alia, comfort, ergonomics or design. The parties concerned shall have access to the requisite test documents drawn up by accredited or authorised laboratories, which shall be attached to the technical documentation, with a view to ensuring that wearers are protected. Once the testing period is over, the PPE used shall be returned to the manufacturers. Field tests shall not be designed to test the protection performance of the PPE, but rather to assess, for example, comfort, ergonomics and design. All parties concerned (e.g. the employer and the wearer or end-user) shall be formally notified in advance of the scope and purpose of the field test.

Amendment 195 #

Proposal for a regulation
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 196 #

Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 1

2. At trade fairs, exhibitions, and demonstrations, Member States shall not prevent the showing of PPE which does not comply with this Regulation provided that a visible signs can be found within the area assigned to the exhibiting party that 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 197 #

Jutta STEINRUCK

Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 2

During demonstrations and time-limited field tests, adequate measures shall be taken to ensure the protection of persons and to raise their awareness. A 'for field test only' marking shall be clearly and indelibly affixed to the PPE.

Amendment 198 #

Proposal for a regulation
Article 7 – paragraph 2 – subparagraph 2

During demonstrations and field tests, adequate measures shall be taken to ensure the protection of persons and to raise their awareness. Field tests shall not only be designed to test the protection performance of the PPE, but to evaluate for instance comfort, ergonomics and design. All concerned parties (e.g. the employer as well as the wearer or end- user) shall be formally informed in advance concerning the scope and the purpose of this test. A 'for field test only' marking shall be clearly and indelibly affixed to the PPE.

Amendment 199 #

Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 2

The ~~design~~manufacturer 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

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

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

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 203 #

Proposal for a regulation
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 end- users, as determined by the Member State concerned as well as, where possible, by pictograms.

Amendment 204 #

Proposal for a regulation
Article 8 – paragraph 9

9. Manufacturers who consider or have reason to believe that PPE which they have placed on the market is not in conformity with this Regulation shall immediately take the necessary corrective measures to bring it into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the PPE presents a risk, manufacturers shall immediately inform the market surveillance authorities of the Member States in which they made the PPE available on the market to that effect, giving details, in particular, of the non- conformity and of any corrective measures taken. The market surveillance authorities then have the obligation to inform the public of the risk as long as the corrective measure is not in place.

Amendment 205 #

Proposal for a regulation
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 and 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 206 #

Emilian PAVEL

Proposal for a regulation
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 to demonstrate the conformity of the PPE, in ~~a language which can be easily understood by~~the official language of 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 207 #

Proposal for a regulation
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 208 #

Jutta STEINRUCK

Proposal for a regulation
Article 8 – paragraph 10

10. Manufacturers shall, further to a reasoned request from a competent national authority, provide it, in electronic or paper form, with all the information and documentation necessary 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

b) further to a reasoned request from a ~~national market surveillance~~competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of ~~the PPE~~an explosive;

Amendment 210 #

Proposal for a regulation
Article 9 – paragraph 2 – point b

(b) further to a ~~reasoned~~ request from a national market surveillance authority, provide that authority with all the information and documentation necessary, in paper and electronic form, to demonstrate the conformity of the PPE;

Amendment 211 #

Proposal for a regulation
Article 9 – paragraph 2 – point c

c) cooperate with the ~~national market surveillance~~competent 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

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 213 #

Emilian PAVEL

Proposal for a regulation
Article 10 – paragraph 3

3. Importers 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 contact details shall be in ~~a language easily understood by~~the official language of the end-users and market surveillance authorities.

Amendment 214 #

Proposal for a regulation
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 215 #

Proposal for a regulation
Article 10 – paragraph 4

4. Importers shall ensure that the PPE is accompanied by the instructions 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 and when possible should be language neutral.

Amendment 216 #

Proposal for a regulation
Article 10 – paragraph 5 a (new)

5a. When deemed appropriate with regard to the risks presented by PPE, importers shall, to protect the health and safety of consumers and other end-users, carry out sample testing of PPE made available on the market, investigate, and, if necessary, keep a register of complaints, of non- conforming PPE and PPE recalls, and shall keep distributors informed of any such monitoring.

Amendment 217 #

Proposal for a regulation
Article 10 – paragraph 6

6. Importers who consider or have reason to believe that PPE which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring the PPE into conformity, to withdraw it or to recall it, as appropriate. Such action should be taken no later than five working works days from the day on which importers become aware of that information. Furthermore, where the PPE presents a risk, importers shall immediately inform the market surveillance authorities of the Member States in which they made the PPE available on the market to that effect, giving details, in particular, of the non- conformity and of any corrective measures taken.

Amendment 218 #

Proposal for a regulation
Article 10 – paragraph 6

6. Importers who consider or have reason to believe that PPE which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring the PPE into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the PPE presents a risk, importers shall immediately inform the market surveillance authorities of the Member States in which they made the PPE available on the market to that effect, giving details, in particular, of the non- conformity and of any corrective measures taken. The market surveillance authorities then have the obligation to inform the public of the risk as long as the corrective measure is not in place.

Amendment 219 #

Proposal for a regulation
Article 10 – paragraph 8

8. Importers shall, further to a ~~reasoned~~ request from a competent national authority, provide it with all the information and documentation, in paper orand electronic form, necessary to demonstrate the conformity of 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 220 #

Proposal for a regulation
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~~ required documents, by the instructions and other in~~struc~~formations 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 221 #

Emilian PAVEL

Proposal for a regulation
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 set out in point 1.4 of Annex II in ~~a language which can be easily understood by~~the official language of the 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 222 #

Proposal for a regulation
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 223 #

Proposal for a regulation
Article 11 – paragraph 2 – subparagraph 2

Where a distributor considers or has reason to believe that PPE is not in conformity with the applicable essential health and safety requirements set out in Annex II, he shall not make the PPE available on the market until it has been brought into conformity. Furthermore, where the PPE presents a risk, the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance authorities. Thereafter, the manufacturer shall immediately recall the EPP from the market. The market surveillance authorities then have the obligation to inform the public of the risk as long as the corrective measure is not in place.

Amendment 224 #

Proposal for a regulation
Article 11 – paragraph 4

4. Distributors who consider or have reason to believe that PPE which they have made available on the market is not in conformity with the requirements of this Regulation shall make sure that the necessary corrective measures are taken to bring it into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the PPE presents a risk, distributors shall immediately inform the market surveillance authorities of the Member States in which they have made the PPE available on the market to that effect, giving details, in particular, of the non- conformity and of any corrective measures taken. The market surveillance authorities then have the obligation to inform the public of the risk as long as the corrective measure is not in place.

Amendment 225 #

Proposal for a regulation
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 II~~compliance with this Regulation may be affected.

Amendment 226 #

Proposal for a regulation
Article 12 – paragraph 1

Amendment 227 #

Proposal for a regulation
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

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

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 230 #

Proposal for a regulation
Article 23 – paragraph 7 – point c

(c) appropriate knowledge and understanding of the essential health and safety requirements set out in Annex II, of the corresponding harmonised standards and of the relevant provisions of Union harmonisation legislation and of relevant national legislation;

Amendment 231 #

Proposal for a regulation
Article 23 – paragraph 9

9. Conformity assessment bodies shall take out liability insurance unless liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the conformity assessmentDoes not affect the English version.

Amendment 232 #

Proposal for a regulation
Article 23 – paragraph 9

9. Conformity assessment bodies shall take out liability insurance unless liability is assumed by the Member State in accordance with national law, or the Member State itself is directly responsible for the conformity assessment.

Amendment 233 #

Proposal for a regulation
Article 23 – paragraph 11

11. Conformity assessment bodies shall participate in, or ensure that their personnel responsible for carrying out the conformity assessment tasks are informed of, the relevant standardisation activities and the activities of the notified body coordination group established under this Regulation and shall apply ~~as general guidance the administrativ~~the decisions and documents produced as a result of the work of that group.

Amendment 234 #

Proposal for a regulation
Article 25 – paragraph 1

1. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractors or the subsidiaryies along the full compliance chain meets the requirements set out in Article 23 and shall inform the notifying authority accordingly.

Amendment 235 #

Proposal for a regulation
Article 39 – title

PSurveillance, control, sanctions and penalties

Amendment 236 #

Proposal for a regulation
Article 39 – paragraph 1

Member States shall lay down the rules on guidance, control and penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. To avoid inaccurate use of the PPE and unintended flaws, Member States shall provide guidance on how to meet the requirements of this Regulation. Member States shall first and foremost provide the necessary guidance on how to meet the requirements of this Regulation. If, however, after receiving the necessary guidance the requirements are still not met, penalties shall be the next step. The penalties provided for must be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by [3 months prior to the date of application of this Regulation] at the latest and shall notify it without delay of any subsequent amendment affecting them.

Amendment 237 #

Proposal for a regulation
Article 39 – paragraph 1

Member States shall lay down the rules on surveillance, control, sanctions and penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties or sanctions provided for must be effective, proportionate and dissuasive. Member States shall notify those provisions to the Commission by [3 months prior to the date of application of this Regulation] at the latest and shall notify it without delay of any subsequent amendment affecting them.

Amendment 238 #

Proposal for a regulation
Annex I – section 2 – point b

~~(b) made-to-measure PPE except where such PPE is intended to protect users against risks listed in Category I.~~deleted

Amendment 239 #

Proposal for a regulation
Annex I – section 3 – introductory part

PPE intended to protect users against very serious risks, such as death or irreversible damage to health. Category III includes exclusively PPE intended to protect users against the following risks:

Amendment 240 #

Proposal for a regulation
Annex I – section 3 – point l a (new)

(la) occupational risk of severe impact to the head.

Amendment 241 #

Proposal for a regulation
Annex II – heading -1 (new)

PRELIMINARY REMARKS 1. The essential health and safety requirements laid down in this Regulation are compulsory. 2. Obligations under essential health and safety requirements apply only where the corresponding risk exists for the PPE in question. 3. The essential requirements are to be interpreted and applied in such a way as to take into account the state of the art and current practice at the time of design and manufacture as well as of technical and economic considerations which are consistent with a high degree of health and safety protection. 4. The manufacturer is under an obligation to carry out a risk assessment in order to identify all the risks which apply to the PPE. The manufacturer shall then design and manufacture it taking into account of the assessment. 5. When designing and manufacturing the PPE, and when drafting the instructions, the manufacturer shall envisage not only the intended use of the PPE, but also the reasonably foreseeable uses. Where applicable, the health and safety of persons other than the user shall be ensured.

Amendment 242 #

Proposal for a regulation
Annex II – part 1 – point 1.2 – point 1.2.1 – point 1.2.1.1

The materials, of which the PPE is made, including any of their possible decomposition products, must not adversely affect the health or safety of users or result in the PPE no longer complying with the essential health and safety requirements laid down in this Regulation.

Amendment 243 #

Proposal for a regulation
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

e) where applicable, the date or period of obsolescence of the PPE or of certain of its components;

Amendment 245 #

Proposal for a regulation
Annex II – part 2 – point 2.12 – paragraph 1

The identification markings or indicators directly or indirectly relating to health and safety affixed to these types of PPE must, if possible, take the form of harmonized pictograms or ideograms. They must be perfectly visible and legible and remain so throughout the foreseeable useful life of the PPE. In addition, these markings must be complete, precise and comprehensible so as to prevent any misinterpretation; in particular, when such markings include words or sentences, the latter must be written in ~~the official language(s) of~~a language easily understood by consumers and end-users, as determined by the Member State where the equipment is ~~to be used~~made available on the market.

Amendment 246 #

Proposal for a regulation
Annex II – part 3 – point 3.9 – point 3.9.1 – paragraph 2

To this end, eye protective ~~glasses~~equipment must be so designed and manufactured as to possess, for each harmful wave length, a spectral transmission factor such that the radiant- energy illumination density capable of reaching the user's eye through the filter is minimized and, under no circumstances, exceeds the maximum permissible exposure value. PPE designed to protect the skin against non-ionising radiation must be capable of absorbing or reflecting the majority of the energy radiated in the harmful wavelengths;

Amendment 247 #

Proposal for a regulation
Annex IV – paragraph 1 – point 1

1. Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4, and ensures and declares on his sole responsibility that the PPE concerned satisfies the applicable ~~essential health and safety requirements referred to in Article 5 and set out in Annex II~~requirements of this Regulation.

Amendment 248 #

Proposal for a regulation
Annex IV – paragraph 1 – point 4 – point 4.1

4.1. The manufacturer shall affix the CE marking to each individual PPE that satisfies the applicable ~~essential health and safety requirements~~requirements of this Regulation.

Amendment 249 #

Claude ROLIN

Proposal for a regulation
Annex V – paragraph 1 – point 9

9. The manufacturer shall keep a copy of the EU type-examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the PPE has been ~~placed~~made available on the market.

Amendment 250 #

Proposal for a regulation
Annex VI – paragraph 1 – point 3 – point 3.1

3.1. The manufacturer shall affix the CE marking to each individual PPE that is in conformity with the type described in the EU type-examination certificate and satisfies the applicable ~~essential health and safety requirements~~requirements of this Regulation.

Amendment 251 #