Regulation (EU) 2016/425 Personal Protective Equipment
SAFEGUARDS | Softlines, Hardlines NO. 100/16
On the 9 March 2016 Regulation (EU) 2016/425 was approved and published in the Official Journal of the European Union on the 31.3.2016. This regulation repeals the PPE Directive 89/686/EEC and replaces it. This document provides a summary of the key changes which will apply.
Directive 89/686/EEC is repealed with effect from 21 April 2018.
EC type-examination certificates (Article 10) approved 89/686/EEC remain valid until 21 April 2023 unless they expire before that date.
For Notified Bodies (NBs) such as SGS United Kingdom Limited (SGS) then there are aspects of the regulation that come in to force on the 21 October 2016.
EU TYPE-EXAMINATION CERTIFICATES
EC Type-examination certificates issued under Article 10 of 89/686/EEC are renamed as EU type-examination certificates and will be issued under Module B in Annex V. These will have a validity of five years.
2016/425 requires the manufacturer to submit an application at the earliest 12 months and at the latest 6 months prior to the expiry date of the EU type-examination certificate. SGS will advise you of when this is due and will ask you if the following apply:
Has the product been modified which could affect the conformity of the product to applicable essential health and safety requirements?
Has the there been a change in the state of the art e.g. a revised harmonised standard issued? If the answers to the above are both “NO” then review will be simple (low cost) and a new certificate issued. Otherwise a revision of the technical file will be required. Our records show that many clients have Article 10 certificates that go back over very many years and it is therefore important that these products are reviewed and SGS is informed of those that are no longer required.
The requirements of the technical file (Annex III) have been re-specified:
(a) a complete description of the PPE and of its intended use;
(b) an assessment of the risks against which the PPE is intended to protect;
(c) a list of the essential health and safety requirements that are applicable to the PPE;
(d) design and manufacturing drawings and schemes of the PPE and of its components, sub-assemblies and circuits;
(e) the descriptions and explanations necessary for the understanding of the drawings and schemes referred to in point (d) and of the operation of the PPE;
(f) the references of the harmonised standards referred to in Article 14 that have been applied for the design and manufacture of the PPE. In the event of partial application of harmonised standards, the documentation shall specify the parts which have been applied;
(g) where harmonised standards have not been applied or have been only partially applied, descriptions of the other technical specifications that have been applied in order to satisfy the applicable essential health and safety requirements; Issued 07 April 2016 Page 2 of 3
(h) the results of the design calculations, inspections and examinations carried out to verify the conformity of the PPE with the applicable essential health and safety requirements;
(i) reports on the tests carried out to verify the conformity of the PPE with the applicable essential health and safety requirements and, where appropriate, to establish the relevant protection class;
(j) a description of the means used by the manufacturer during the production of the PPE to ensure the conformity of the PPE produced with the design specifications;
(k) a copy of the manufacturer's instructions and information set out in point 1.4 of Annex II;
(l) for PPE produced as a single unit to fit an individual user, all the necessary instructions for manufacturing such PPE on the basis of the approved basic model;
(m) for PPE produced in series where each item is adapted to fit an individual user, a description of the measures to be taken by the manufacturer during the fitting and production process to ensure that each item of PPE complies with the approved type and with the applicable essential health and safety requirements. 31.3.2016 L 81/85 Official Journal of the European Union EN SGS recommends that this listing be adopted in new technical submissions you make which will make subsequent renewals easier to process.
PPE PRODUCTS INCLUDED
The definition of PPE has been modified as follows:
(a) equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety;
(b) interchangeable components for equipment referred to in point (a) which are essential for its protective function;
(c) connexion systems for equipment referred to in point (a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use.
Under 89/686/EEC PPE for private use against heat (gloves etc.) was excluded. This is now included.
The definition of Category I products have been refined to include protection against the following minimal risks:
(a) superficial mechanical injury;
(b) contact with cleaning materials of weak action or prolonged contact with water;
(c) contact with hot surfaces not exceeding 50 °C;
(d) damage to the eyes due to exposure to sunlight (other than during observation of the sun);
(e) atmospheric conditions that are not of an extreme nature.
The Category III products have also been redefined to include exclusively the risks that may cause very serious consequences such as death or irreversible damage to health relating to the following:
(a) substances and mixtures which are hazardous to health;
(b) atmospheres with oxygen deficiency;
(c) harmful biological agents;
(d) ionising radiation;
(e) high-temperature environments the effects of which are comparable to those of an air temperature of at least 100 °C;
(f) low-temperature environments the effects of which are comparable to those of an air temperature of – 50°C or less;
(g) falling from a height;
(h) electric shock and live working;
(j) cuts by hand-held chainsaws;
(k) high-pressure jets;
(l) bullet wounds or knife stabs;
(m) harmful noise.
As before Category II products are those that are not Category I or III
CONFORMITY ASSESMENT PROCEDURES
Category II: EU type-examination (module B) set out in Annex V, followed by conformity to type based on internal production control (module C) set out in Annex VI
Category III: EU type-examination (module B) set out in Annex V, and either of the following:
(i) conformity to type based on internal production control plus supervised product checks at random intervals (module C2) set out in Annex VI (this is equivalent to the old Article 11A)
(ii) conformity to type based on quality assurance of the production process (module D) set out in Annex VIII. (this is equivalent to the old Article 11B
By way of derogation, for PPE produced as a single unit to fit an individual user and classified according to Category III, the procedure referred to for Category II may be followed.
OBLIGATIONS OF MANUFACTURERS
This is a new section but pulls information in 89/686/EEC into Article 8. Importantly there are additional requirements in the clauses shown below:
(4) When deemed appropriate with regard to the risks presented by PPE, manufacturers 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.
(5) Manufacturers shall ensure that the PPE which they place on the market bears 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 in a document accompanying the PPE.
(8) The manufacturer shall either provide the EU declaration of conformity with the PPE or include in the instructions and information set out in point 1.4 of Annex II the internet address at which the EU declaration of conformity can be accessed.
(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 corrective measures necessary to bring that PPE into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the PPE presents a risk, manufacturers shall immediately inform the competent national 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.
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