Personal Protective Equipment (PPE) – Regulation (EU) 2016/425
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. The PPE Directive was one of the first New Approach Directives and is now over 20 years old. In order to reflect current technologies and processes for developing and bringing PPE to the market, it is in the process of being superseded by a new PPE Regulation (EU) 2016/425. On April 21, 2018, Directive 89/686/EEC will be repealed and replaced with Regulation (EU) 2016/425. The change imposes new conditions upon manufacturers and suppliers of PPE in Europe, including the following additional requirements:
- New responsibilities for importers and distributors
- Products that are bespoke and/or for private use are covered by the Regulation
- Some products which were Category II are now moved to 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
- Instructions for use, labelling and EU Declaration of Conformity must be supplied with PPE and in the language easily understood by consumers and end users
Key dates in the progression of EU Law relating to PPE:
- The PPE Directive 89/686/EEC is repealed with effect from 21 April 2018.
- The new PPE Regulation (EU) 2016/425 shall apply from 21 April 2018.
- Member States shall not impede the making available on the market of products covered by the old PPE Directive 89/686/EEC before 21 April 2019.
- EC type-examination certificates issued under Directive 89/686/EEC shall remain valid until 21 April 2023 unless they expire before that date.
PPE: Definition under the new regulation 2016/425
- 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
PPE compliance Under 2016/425
PPE products are classified into one of three categories, depending upon the level of risk associated with their use. (see table below):
PPE in this category is designed to protect users against minimal risks. These include as examples: superficial mechanical injury; contact with water or cleaning materials of weak action; 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 II includes risks other than those listed in Categories I and III. The following products are included as examples: Safety spectacles and goggles, Industrial helmets and bump caps, hi visibility clothing
PPE falling under this category ‘includes exclusively the risks that may cause very serious consequences such as death or irreversible damage to health’ Risks include: substances and mixtures which are hazardous to health; atmospheres with oxygen deficiency; harmful biological agents; ionising 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.
PPE Compliance under 2016/425 compared with 89/686/EEC
|PPE Directive 89/686/EEC||PPE Regulation 2016/425|
|Category I||Manufacturers self-declaration||Module A (Annex IV): Internal production control|
|Category II||Article 10 : EC type-Examination |
Internal Control of Production
|Module B (Annex V): EU Type Examination |
Module C (Annex VI): Conformity to type based on internal production control
|Category III||Article 10 : EC type-Examination |
Article 11a: EC quality control system for the final product
Article 11b: System for ensuring EC quality of production by means of monitoring
|Module B (Annex V): EU Type Examination |
Module C2 (Annex VII): Conformity to type based on internal production control plus supervised product checks at random intervals
Module D (Annex VIII): Conformity to type based on quality assurance of the production process
PPE covered by categories II and III require the product to be certified by a Notified Body (NB). The Notified Body will issue an EU type-examination certificate on successful evaluation of a manufacturer’s technical file and independent testing report. The Notified Body will review the technical documentation against the essential health and safety requirements associated with the appropriate harmonized standard(s). EU type-examination certificates will be issued for a maximum term of five years, after which the manufacturer must reapply to the Notified Body for renewal. Assessment for renewal purposes will depend upon whether any significant changes have been made to the relevant standards, and of course, whether there are any necessary changes to the certified design.
Category II product manufacturers must follow Module C whereby the manufacturer (or authorised representative based in the EU), shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured PPE with the type described in the EU type-examination certificate and with the applicable requirements of the PPE Regulation. The manufacturer will ensure compliance with all relevant European legislation before applying the CE mark and creating the accompanying Declaration of Conformity.
Category III product manufacturers must also undertake ongoing assessment to check compliance, either by periodic site audits, to ensure quality management systems are in place, or compliance testing of samples.
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:
- 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.
- PPE marking will include 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. PPE bearing identification markings or indicators directly or indirectly relating to health and safety, must, if possible, take the form of harmonised pictograms or ideograms. If it is known that the design performance of new PPE may be significantly affected by ageing, the month and year of manufacture and/or, if possible, the month and year of obsolescence must be indelibly and unambiguously marked on each item of PPE placed on the market and on its packaging. Alternatively, instructions must provide all the information necessary to enable the purchaser or user to establish a reasonable obsolescence month and year.
- The manufacturer shall either provide the EU declaration of conformity accompanying each PPE product or include in the instructions and if relevant, 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.
The Regulation (EU) 2016/425 uses a new term “Economic Operators” which it defines as anyone “intervening in the supply & distribution chain or PPE Products”so it includes manufacturers, authorised representatives, importers & distributors (including on-line vendors for the first time) and it requires them to take appropriate actions to ensure their PPE products are fully in conformity with the Standard claimed. There will be new obligations upon manufacturers, importers & distributors to hold copies of PPE Technical Files, Product Type Examination Certificates and Declarations of Conformity & keep records of these documents for at least 10 years, ensure User Instructions are provided with each product and in the correct language, ensure that transport & storage do not harm the PPE’s efficacy or Conformity & to indicate on the PPE their Product Code or I.D. & postal address where they may be contacted. Note that Distributors & Importers who place PPE on the market under their own Name or Brand take on ALL the obligations of the manufacturer.
Obligations for all economic operators can be seen in Chapter II of the Regulation.
For more information on the Regulation and its application, contact SIRA CERTIFICATION SERVICE and/or please access the following key documents:
PPE Regulation 2016/425