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With the repeal of Directive 89/686/EEC and adoption of Regulation (EU) 2016/425 on April 21, 2018, how will personal protective equipment certification change in Europe?

Safety First

The global personal protective equipment (PPE) market is estimated to be worth around US $40 billion in 2017, with expectations that it will rise to US $58 billion by 2022. Safety footwear accounted for US $5 billion in 2015 and it is predicted this sector alone will rise by 5% year-on-year. Protective clothing is currently the fastest growing sector of PPE, representing 22% of sales in 2016. Looking ahead, the hand and arm protection segment is expected to lead the PPE market.

Within the European Union (EU), PPE is currently regulated by Directive 89/686/EEC. It covers most domestic, leisure and professional safety products, requiring all PPE products to meet Basic Health and Safety Requirements (BHSR), as defined in Annex II.

On April 21, 2018, Directive 89/686/EEC will be repealed and replaced with Regulation (EU) 2016/425. The change is more than cosmetic, it imposes new conditions upon manufacturers and suppliers of PPE in Europe, including the following additional requirements:

  • New responsibilities for importers and distributors
  • Products that protect from heat for private use (oven gloves) are now PPE
  • Some products which were Category II are now Category III
  • An assessment of the risks against which the PPE is intended to protect
  • Changes in requirements for product marking, including manufacturer name, registered trade name or registered trade mark, and postal address
  • Changes in requirements for instructions for use to include the internet address where the EU Declaration of Conformity can be accessed

PPE: Definition under the new regulation

  • 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
  • Interchangeable components for equipment referred to in point (a) which are essential for its protective function
  • Connection 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

Certifying PPE Under 2016/425

PPE products are classified into one of three categories, depending upon the level of risk associated with their use. (see Table 1)

Table 1. PPE Categories

Category I Category II Category III

Protect against ‘minimal risk’:

  • superficial mechanical injury
  • contact with cleaning materials of weak action or prolonged contact with water
  • contact with hot surfaces not exceeding 50 °C
  • damage to the eyes due to exposure to sunlight (other than during observation of the sun)
  • atmospheric conditions that are not of an extreme nature
Includes risks other than those listed in Categories I and III

Includes exclusively the risks that may cause very serious consequences such as death or irreversible damage to health relating to the following:

  • substances and mixtures which are hazardous to health
  • atmospheres with oxygen deficiency
  • harmful biological agents
  • ionizing radiation
  • high-temperature environments the effects of which are comparable to those of an air temperature of at least 100 °C
  • low-temperature environments the effects of which are comparable to those of an air temperature of – 50°C or less
  • falling from a height
  • electric shock and live working
  • drowning
  • cuts by hand-held chainsaws
  • high-pressure jets
  • bullet wounds or knife stabs
  • harmful noise

2016/425 defines different conformity assessment procedures, depending on the category of PPE. (see Table 2) In all cases an EU Declaration of Conformity is required.

Table 2. Conformity Assessment Procedures

Category I Manufacturers self-certification
Category II EU type-examination (module B)
Category III

EU type-examination (module B) and either of the following:

  • conformity to type based on internal production control plus supervised product checks at random intervals (module C2) set out in Annex VII
  • conformity to type based on quality assurance of the production process (module D) set out in Annex VIII

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 in Category II may be followed.

Category II and Category III PPE products both require the manufacturer to produce an EU Type Examination, including certification by a Notified Body (NB). This can be achieved by developing a Technical File with an independent testing report. In addition to this, Category III product manufacturers must also undertake ongoing assessment to check compliance. This requires the NB to annually undertake site audits, to ensure quality management systems are in place, and compliance testing of samples.

When preparing the necessary technical documentation for certification under Regulation 2016/425, manufacturers must demonstrate their product complies with the essential requirements relating to it. For EU Type Examination, the NB will normally review the technical documentation against the essential health and safety requirements associated with the appropriate harmonized standard.

Obligations of manufacturers

This is a new section but draws 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.

Planning for Transition?

Manufacturers and suppliers of PPE need to be ready for the change to ensure continuous compliance with European law. The key dates are:

  • April 21, 2018 – all new products placed onto the market must conform to Regulation 2016/425
  • April 21, 2019 – existing products, currently offered for sale, must receive certification to Regulation 2016/425

SGS Solutions: Transitioning from PPE Directive to Regulation

With a network of over 40 accredited laboratories around the world, SGS provides a one-stop shop solution for achieving compliance with European PPE legislation. As a NB, we offer a comprehensive range of physical, chemical and functional testing services for components, materials and finished products, and provide certification services against the new requirements for Module B, the EU Type Examination, the replacement for Article 10, and Modules C2 and D for production certification, which replace Articles 11A and 11B.

We have also developed a simple procedure to help manufacturers of products, where the ‘state of the art’ (harmonized standard) has not changed, transition from PPE Directive to Regulation. To utilize this, the contact details of the certificate holder, or where the product is made, must not have changed, and there must be not modifications to the certified product(s).

A Notified Body

For Category II and III PPE products, we are accredited as a NB for both the outgoing Directive 89/686/EEC and incoming Regulation (EU) 2016/425, making SGS the ideal partner for European PPE product compliance.

To learn more about the EU’s new PPE Regulation, see us at A+A 2017 in Düsseldorf, October 17-20. Our experts will be available throughout the exhibition on Booth C15, Hall 11.

For more information, visit A+A 2017 page.

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For further information, please contact:

P Venkatesan
Global PPE & Leather / Footwear Manager
SGS India Private Limited.
t: +91 44 66081620

Peter Downs
PPE Certification Manager
SGS UK
t: +44 (0) 1934 529263