SGS Helps Manufacturers Stay Compliant with New European PPE Regulations

Globally, PPE is estimated to be worth around US $40 billion and it is expected this figure will rise to US $58 billion by 2022. In the US, safety footwear accounts for over US $5 billion and this sector alone is expected to rise by 5% year-on-year. Protective clothing is the fastest growing sector of PPE, representing 22% of sales in 2016. In the future, it is predicted the hand and arm protection segment will lead the global PPE market.

In 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. However, on April 21, 2018, Directive 89/686/EEC will be repealed and replaced by Regulation (EU) 2016/425. The change imposes several new conditions upon manufacturers and suppliers of PPE in Europe. These include:

• 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

The new regulation defines PPE as:

• Equipment that is 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

One of the changes brought in by Regulation (EU) 2016/425 is the way in which PPE are categorized. The three categories represent the different levels of protection and threat. They are:

Category I – 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

Category III - includes exclusively the risks that may cause very serious consequences such as death or irreversible damage to health relating to:
• 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

Category II – products that are not Category I or Category III

Depending on the category of PPE, Regulation (EU) 2016/425 defines different conformity assessment procedures. In all cases an EU Declaration of Conformity is required. The requirements are:

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.

The manufacturer must produce an EU Type Examination, including certification by a Notified Body (NB), for both Category II and Category III PPE products. This can be achieved by developing a Technical File with an independent testing report. Category III products must also undergo ongoing assessment to check compliance. The NB must undertake site audits every year, ensuring quality management systems are in place, and conduct compliance testing of samples.

When preparing the necessary technical documentation for certification under Regulation 2016/425, manufacturers are required to demonstrate their products comply 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.

Regulation (EU) 2016/425 has also introduced a new section – Obligations of Manufacturers – drawing some information from 89/686/EEC into Article 8. The important additional requirements are shown in the clauses 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.

Manufacturers and suppliers of PPE must ensure they are ready for the changeover to ensure continued compliance. 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 PPE Services
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, SGS offers 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.

They 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).

SGS is 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.

Learn more about SGS’s Softline Services [www.sgs.com/softlines]

For further information contact:

P Venkatesan
Global PPE & Leather / Footwear Manager

Peter Downs
PPE Certification Manager
Email: crs.media@sgs.com
Website: www.sgs.com/softlines

About SGS
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 90,000 employees, SGS operates a network of over 2,000 offices and laboratories around the world.

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This release was published on openPR.