31 Amendments of Anthea McINTYRE related to 2014/0108(COD)
Amendment 141 #
Proposal for a regulation
Recital 9
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 ensurprovide 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/EECd 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 areshould 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 143 #
Proposal for a regulation
Recital 10
Recital 10
Amendment 145 #
Proposal for a regulation
Recital 10 a (new)
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 147 #
Proposal for a regulation
Recital 11
Recital 11
(11) Economic operators should be responsible for the compliance of productsthe 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 149 #
Proposal for a regulation
Recital 12
Recital 12
(12) All economic operators intervening in the supply and distribution chain should take appropriate measures to ensure that PPE protects the health and safety of persons and that they make available on the market only products which complPPE 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 161 #
Proposal for a regulation
Recital 21
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 165 #
Proposal for a regulation
Recital 28
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 175 #
Proposal for a regulation
Recital 36
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 177 #
Proposal for a regulation
Article 2 – paragraph 2 – point c
Article 2 – paragraph 2 – point c
(c) intended for private use to protect against atmospheric conditions that are not of an extreme nature;:
Amendment 178 #
Proposal for a regulation
Article 2 – paragraph 2 – point c – point i (new)
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)
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)
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 182 #
Proposal for a regulation
Article 2 – paragraph 2 – point e
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), of two- or three- wheeled motor vehiclen uniform provisions concerning the approval of protective helmets and of their visors for drivers and passengers of motor cycles and mopeds.
Amendment 185 #
Proposal for a regulation
Article 3 – paragraph 1 – point 1 – point a
Article 3 – paragraph 1 – point 1 – point a
(a) equipment intenddesigned and manufactured to be worn or held by a person for protection against one or more risks for his or her health or safety that is placed on the market separately or combined with personal non-protective equipment;
Amendment 186 #
Proposal for a regulation
Article 3 – paragraph 1 – point 1 – point c
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 190 #
Proposal for a regulation
Article 3 – paragraph 1 – point 18 a (new)
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 216 #
Proposal for a regulation
Article 10 – paragraph 5 a (new)
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 220 #
Proposal for a regulation
Article 11 – paragraph 2 – subparagraph 1
Article 11 – paragraph 2 – subparagraph 1
2. Before making PPE available on the market, distributors shall verify that it bears the CE marking, is accompanied by the EU declaration of conformity or a simplified EU declaration of conformity, and that it is accompanied by required documents, by the instructions and other instrucformations 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 226 #
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
An importer or distributor shall be considered a manufacturer for the purposes of this Regulation and he shall be subject to the obligations of the manufacturer set out in Article 8 where he places PPE on the market under his name or trademark or modifies PPE already placed on the market in such a way that the conformity with the applicable essential health and safety requirements set out in Annex IIcompliance with this Regulation may be affected.
Amendment 230 #
Proposal for a regulation
Article 23 – paragraph 7 – point c
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 232 #
Proposal for a regulation
Article 23 – paragraph 9
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
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 administrativthe decisions and documents produced as a result of the work of that group.
Amendment 239 #
Proposal for a regulation
Annex I – section 3 – introductory part
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 241 #
Proposal for a regulation
Annex II – heading -1 (new)
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
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 245 #
Proposal for a regulation
Annex II – part 2 – point 2.12 – paragraph 1
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) ofa language easily understood by consumers and end-users, as determined by the Member State where the equipment is to be usedmade available on the market.
Amendment 246 #
Proposal for a regulation
Annex II – part 3 – point 3.9 – point 3.9.1 – paragraph 2
Annex II – part 3 – point 3.9 – point 3.9.1 – paragraph 2
To this end, eye protective glassesequipment 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
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 IIrequirements of this Regulation.
Amendment 248 #
Proposal for a regulation
Annex IV – paragraph 1 – point 4 – point 4.1
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 requirementsrequirements of this Regulation.
Amendment 250 #
Proposal for a regulation
Annex VI – paragraph 1 – point 3 – point 3.1
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 requirementsrequirements of this Regulation.
Amendment 251 #
Proposal for a regulation
Annex VII – paragraph 1 – point 1
Annex VII – paragraph 1 – point 1
1. Conformity to type based on product verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3, 5.2 and 6, and ensures and declares on his sole responsibility that the PPE, which has been subject to the provisions of point 4, is in conformity with the type described in the EU type- examination certificate and satisfies the applicable essential health and safety requirements referred to in Article 5 and set out in Annex IIrequirements of this Regulation.