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Regulation 425/2016/EU was approved on 9 March 2016 and published in the Official Journal of the European Union on 31 March 2016. This regulation will repeal the Personal Protective Equipment (PPE) Directive 89/686/EEC and replace it.

Important Dates

  • Directive 89/686/EEC is repealed with effect from 21 April 2018
  • EC type-examination certificates (Article 10) approved in accordance with 89/686/EEC remain valid until 21 April 2023, unless they expire before that date
  • Items (such as oven gloves and mitts) not previously certified will need to be withdrawn from sale before this date

EU Type-Examination Certificates

EU type-examination certificates will be issued under Module B in Annex V. These will have a validity of five years.

Technical Documentation

The requirements of the technical file (Annex III) have been re-specified. For oven gloves, these will include:

(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

(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;

PPE Products Included

PPE is defined as 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. Under 89/686/EEC, PPE for private use against heat (e.g. oven gloves and mitts) was excluded from this definition It is now included.

As Category I products are limited to those which protect against contact with hot surfaces not exceeding 50°C, oven gloves and mitts cannot be included in Category I and must be included in Category II. This will require a formal conformity assessment as delineated below.

Conformity Assessment Procedures

Category II

Category II products require 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.

The protection against contact heat in particular is, of course, a key issue with oven gloves and mitts. Whilst previously, testing would have been carried out against national standards such as BS 6526:1998 as a matter of due diligence, it is probable that in future oven gloves will need to be tested against European standards. Currently the most appropriate are EN 407 “Protective gloves against thermal risks (heat and/or fire)” and EN 420:2003+A1:2009 “Protective gloves. General requirements and test methods”.  In reality, it seems likely that in order to truly cover all of the essential health and safety requirements for specific items such as oven gloves and mitts and therefore assure conformity with the regulation, a combination of these two  European standards and the British standard (or similar national standard) may be required. Study of the next section is therefore essential to ensure that all obligations are covered.

Obligations of Manufacturers

This is a new section; however, it pulls information from  89/686/EEC into Article 8. Importantly, there are additional requirements in the clauses shown below:

  • 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
  • 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
  • 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
  • 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

For more information on this subject contact:

Robert Croskell BTech CText FTI
Softlines Specialist
t: +44 (0)1379 668625
e: +44 (0)7730 544718
f: +44 (0)1379 668625
e:Rob.Croskell@sgs.com

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