Last reviewed 30 August 2018
Gordon Tranter discusses the relevance of the new EU Personal Protective Equipment (PPE) Regulation 2016/425 to those handling chemicals.
New Approach Directives
Directive 89/686/EEC, the New Approach Directive, on the approximation of the laws of the Member States relating to PPE was repealed and replaced on 21 April 2018 by EU PPE Regulation 2016/425.
The principal aim of the New Approach Directives is to standardise and harmonise legislation and guidelines for different products or product sectors on the EU market. This is achieved by a set of requirements that all manufacturers must adhere to before those products covered by New Approach Directives can be officially placed on the market within the European Economic Area (EEA), the European Member States and the three European Free Trade Association States (Iceland, Liechtenstein and Norway).
Most of the Directives, and in a few cases regulations, set common minimum health and safety objectives (the essential health and safety requirements (ESHR)) specific for each product and require the product to be CE marked.
CE marking is a self-certification scheme by which the responsible person declares conformity with the applicable directives relating to that product. If a product has minimal risk, it can be self-certified by a manufacturer making a Declaration of Conformity and affixing the CE marking to its own product. Each directive specifies those products for which there is a requirement for an authorised third party (the notified body) to be involved in the conformity assessment procedure necessary for CE marking. The notified body issues an EC-type examination certificate to declare conformity.
The responsible person for CE marking is the person who places the product on the market, or puts it into service, for the first time. In most cases this is either the manufacturer or the manufacturer’s authorised representative, but it can also include those who import non-CE marked products into Europe.
The CE mark and the Declaration of Conformity — a document the manufacturer signs to say that the product meets all the requirements of the applicable directives — together give the product a presumption of conformity with relevant product safety directives.
Only those product categories subject to relevant directives or regulations can bear CE markings. CE markings must not be affixed to any other product.
Self-declaration and certification
CE marking is not a quality assurance declaration. It does not show evidence of third-party testing, and it should not be confused with any independent certification mark of the type issued by international or European notified test bodies.
A harmonised standard is a European standard developed by a recognised European Standards Organisation: CEN, CENELEC or ETSI. It is created following a request from the European Commission to one of these organisations. Manufacturers, other economic operators, or conformity assessment bodies can use harmonised standards to demonstrate that products, services, or processes comply with relevant new Approach Directives.
EU PPE Regulation 2016/425 on personal protective equipment
On 21 April 2018, EU PPE Regulation 2016/425 on PPE revoked and replaced Directive 89/686/EEC on PPE. The EU PPE Regulation 2016/425 applies to each individual item of PPE intended to be placed and/or put into service on the EU market for the first time. It requires all PPE placed on the market within the EEA to comply with the regulation and not to endanger persons and properties. All PPE must meet the essential health and safety requirements (Annex II) and this is specified in the PPE’s EU Declaration of Conformity.
EU PPE Regulation 2016/425 allows products covered by the PPE Directive 89/686/EEC, which are in conformity with that directive and which were placed on the market before 21 April 2019 and products already in the distribution chain by that date, to continue to be sold after that date and until 21 April 2023. EC-type examination certificates and approval decisions issued under Directive 89/686/EEC will remain valid until 21 April 2023 unless they expire before that date.
UK implementing legislation
The Personal Protective Equipment Regulations 2002 require that PPE placed on the market by suppliers should conform with the requirements of the PPE Directive and specifies how the directive was to be implemented in the UK. These regulations should not be confused with the Personal Protective Equipment at Work Regulations 1992, which require employers who provide PPE for use at work to ensure that suitable PPE is provided to their employees.
The Personal Protective Equipment (Enforcement) Regulation 2018 revokes the Personal Protective Equipment Regulations 2002 and provide for enforcement, offences and penalties under the EU PPE Regulation in the UK. The EU PPE Regulation has not applied any new duties to those purchasing PPE for use within their organisation, although they are still legally required to adhere to the Personal Protective Equipment at Work Regulations 1992.
It should be noted that the Personal Protective Equipment Regulations 2002 will still apply to products covered by the PPE Directive and placed on the market before 21 April 2019 (see the transitional arrangements in the following section).
The need for PPE to be CE marked
The Personal Protective Equipment at Work Regulations 1992 include a requirement that personal protective equipment provided to employees must be suitable and bear a “CE” mark and comply with EU PPE Regulation 2016/425 and the PPE Directive. Although this requirement does not apply to the following regulations where any of them require the provision or use of personal protective equipment:
Control of Lead at Work Regulations 2002
Ionising Radiations Regulations 2017
Control of Asbestos Regulations 2012
Control of Substances Hazardous to Health Regulations 2002
which contain the same requirement for PPE to bear a CE mark.
Changes made by EU PPE Regulation 2016/425
EU PPE Regulation 2016/425 was introduced because the PPE Directive had limitations, in particular:
there were concerns that product’s coverage and conformity assessments were inadequate and inconsistent
technologies and processes for developing and bringing PPE to the market had changed.
EU PPE Regulation 2016/425 maintains the three categories used in the PPE Directive:
Category I: Simple PPE
Category II: Intermediate PPE
Category III: Complex PPE.
However, it replaces the list of PPE in each category with the following risk categories:
Category I: exclusively for minimal risks, including of relevance to chemicals contact with cleaning materials weak action or prolonged contact with water
Category II: risks other than those listed in Categories I and III
Category III: includes exclusively the risks that may cause very serious consequences such as death or irreversible damage to health, including of relevance to chemicals:
substances and mixtures hazardous to health
oxygen deficient atmospheres
harmful biological agents
The risks from harmful biological agents have been moved from Categories II to III.
Conformity assessment procedures
More stringent conformity assessment procedures have been introduced.
EU Declaration of Conformity
The manufacturer is required to either provide the EU Declaration of Conformity with the PPE or include in the product’s user instructions, information or weblink, where the Declaration of Conformity can be accessed.
The European Commission has issued three communications listing the titles and references of harmonised standards that can be used to demonstrate that PPE products comply with EU PPE Regulation 2016/425.
See Official Journal:
2018/C 209/03 (Corrected by: 2018/C 222/14)
Safety managers and the changes
EU PPE Regulation 2016/425 contains no requirements that directly impact upon users but it effects Personal Protective Equipment at Work Regulations 1992 requirement for PPE to bear a “CE”. This means that when purchasing PPE, safety managers need to take a proactive approach to ensure the products are compliant and meet the new regulatory requirements.
This does not mean that all PPE must be CE marked under the EU PPE Regulation. Following the changes introduced by the EU PPE Regulation 2016/425, safety managers will be able to procure PPE in accordance with the PPE Directive until 21 April 2023. The product will have to have an EU Declaration of Conformity and, if necessary, a current EC-type examinations certificate. If the certificate expires before 21 April 2023, then the products will have to be removed from the market or re-certified to the EU PPE Regulation 2016/425. After 21 April 2019, all newly imported products are required to be re-certified to the EU PPE Regulation 2016/425.
Steps safety managers should take to ensure the products are compliant include checking:
with suppliers that the PPE that has changed category under the EU PPE Regulation is now re-certified to the new regulation. This includes PPE for risks from harmful biological agents which has been moved from Categories II to III
to see if there has been a change in the state of the art or standards of the PPE being purchased and whether it complies with the most current standard.
The potential impact of Brexit on the EU PPE Regulation 2016/425
The effect of the UK coming out of the EU is currently unknown. The PPE market in the UK has been based on EU directives for a generation. It took years of discussion involving a considerable input from the UK before the EU PPE Regulation was agreed.
CE marked under the EU PPE Regulation 2016/425
Those who use PPE for providing protection against health and safety hazards should be aware that products can be given a CE marking under several directives and PPE could be certified under another directive and CE marked accordingly. Consequently, those purchasing PPE should ask for confirmation, from the supplier, that the PPE certified satisfies the requirements of the EU PPE Regulation or has been certified under the PPE Directive and placed on the market before 21 April 2019.
Directive 89/686/EEC, the New Approach Directive on PPE was repealed and replaced by EU PPE Regulation 2016/425 on 21 April 2018.
There is a transitional arrangement whereby products in conformity with Directive 89/686/EEC can be made available if placed on the market before 21 April 2019.
EU PPE Regulation 2016/425 requires manufacturers, their authorised representatives and importers to CE mark their PPE and accompany it with an EU Declaration of Conformity and, if necessary, a current EC-type examinations certificate.
EU PPE Regulation 2016/425 contains no requirements that directly impact upon users, but it effects the implementation of the requirement in the Personal Protective Equipment at Work Regulations 1992 for PPE to bear a “CE” mark.
Now EU PPE Regulation 2016/425 is in force, safety managers need to take a proactive approach to ensure the PPE products they purchase are compliant and meet the new regulatory requirements.