New European regulation for personal protective equipment

16 September 2016

What are the consequences of the new regulations for all stakeholders ?

On 31 March 2016, the new European Regulation 2016-425 on personal protective equipment was published . This Regulation contains updates and stricter rules for placing personal protective equipment (PPE) on the market in the European Union (EU).

PPE are 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.

The PPE Regulation, which is to replace the current Directive 89/686/EEC on PPE, entered into force on 21 April 2016, twenty days after publication in the Official Journal of the European Union. Only 24 months later, on 21 April 2018, the Regulation will be fully effective and replace Directive 89/686/EEC. Market participants such as manufacturers, importers, distributors and inspection bodies have two years left, in which to prepare for the new rules.

Unlike the current PPE Directive, the new Regulation does not have to be transposed into national legislation but applies directly to all European Member States. The Member States must, however, repeal the current national legislation . Only the punishment in the event of an infringement of the Regulation will be enacted in national legislation.

In addition to the reclassification of certain products and the introduction of a 5-year limit of validity for CE certificates, one of the most important changes in the new PPE Regulation is that it clearly describes the obligations of all market participants. The new Regulation also clearly stipulates that an importer or distributor who places a product on the market in Europe under its own name, brand or trademark, shall assume the obligations of the manufacturer. These are considerably clearer rules for the entire supply chain. It is thus essential for all parties to know what their responsibilities are and for companies that purchase PPE for their workers to know what they can expect from their suppliers.

The history of the European legislation on PPE

The PPE Directive of 1989 was one of the first of the ‘new approach’ directives. In order to make European one single market, the European Union (EU),more than 20 years ago, started to implement what was known as the ‘new approach’.
The most important goal of this new approach was to lift the trade barriers by imposing common health and safety requirements for all products, which were supported by standards agreed at product level. The aim is of this framework was to apply throughout the EU and by the other trading partners of the European Economic Area (EEA). Generally speaking, the PPE Directive is assumed to have been successful; it led to harmonized standards for PPE, lifted trade barriers and contributed to the development of a single European PPE market.

Why change the PPE Directive?

The Directive has its limitations.
There was a concern that there were insufficient products included, and that the conformity assessments were inadequate and inconsistent.
Questions arose about the effectiveness of market surveillance.
The technologies and processes for developing and placing PPE on the market have changed.

After consultation with the main parties, it was decided to make a few major changes and to convert the Directive into a Regulation. As mentioned, the new PPE Regulation entered into force 20 days after its publication, on 31 March 2016, in the Official Journal of the European Union. For a few specific sections of the Regulation, the date of entry into force is not until 21 April 2018. EU type-examination certificates that have already been issued remain valid until 21 April 2023, provided they do not become invalid for any other reason such as expiry dates, changes in classification or products for which a new assessment is required.

Transitional periods

Transitional period and entry into force PPE Directive. During the transitional period, certificates issued before 21 April 2018 on the basis of the current Directive 89/686/EEC will remain valid until 21 April 2023.

Notified bodies

Notified bodies are the assessment and certification bodies.

Provisions concerning notified bodies take effect six months after the entry into force of the PPE Regulation.
In order to allow the notified bodies to carry out their certification process, manufacturers must submit their application at the earliest 12 months and at the latest 6 months before the certificate expires.

PPE categories

Each PPE category must comply with clearly defined conformity assessments modules before they can be placed on the market. These categories are:

Category 1 PPE against low risks

PPE in this category are designed to protect people from limited risks.
These are:

superficial mechanical injury
contact with cleaning materials of weak action or prolonged contact with water
contact with warm surfaces not exceeding 50°C
damage to the eyes due to exposure to sunlight (other than during observation of the sun)
no extremely weather conditions

Manufacturers of PPE against these low risks may determine the protection level of a product by means of internal production control, followed by conformity to the type without verification by a certified assessment (notified) body.

Category 2 PPE against medium-high risks

This category comprises risks other than those mentioned in categories 1 or 3. PPE of category 2 belong to an EU type-examination by a notified body, after which the manufacturer must provide the client with a declaration of conformity. The manufacturer must also have an internal production control process in order to guarantee that the product remains in conformity with the type.

Category 3 PPE against high risks

Category 3 PPE are designed to protect people against risks that may cause very serious consequences such as death or irreversible damage to health. Category 3 includes the following risks:

substances and mixtures which are hazardous to health
atmospheres with oxygen deficiency
ionising radiation
warm environments the effects of which are comparable to those of an air temperature of at least 100°C
cold 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

Changes

The following risks are added to Category 3:

harmful biological agents
drowning
cuts by chainsaws
high-pressure jets
bullet wounds or knife stabs
harmful noise

Manufacturers of category 3 PPE are subject to an EU type-examination by a certified assessment body and within one of two quality assessment procedures, either under their own quality system or annually by a notified body.

Some types of protection have moved from category 2 to category 3

All types of hearing protection against harmful noise have been shifted to category 3 (high risks). This category is intended to protect against high risks and where the danger is not immediately obvious. The new classification means that these objects now belong to the strictest conformity assessment procedure, for which the EU type-examination plus regular monitoring of the production process and quality assurance are required.

EU type-examination certificates are valid for five years

EU type-examination certificates for categories 2 and 3 must be limited in time to a maximum of five years. This brings the PPE Regulation in line with comparable European requirements such as the Medical Devices Directive. The reason for this adjustment is that at present there are still PPE on the market that were certified under standards dating from before the turn of the century. Meanwhile, current insights into production improvement and the state of technology today make it possible to create safer products.

Declaration of conformity in all cases

There is currently an obligation to issue a declaration of conformity for all PPE that are placed on the market. A declaration of conformity is a legal document signed by the manufacturer to confirm that the product meets all the requirements of the applicable legislation. The declaration must be draw up by the manufacturer, or by the person (importer) that brings the product to the EU market when the manufacturer is not based in Europe.

Obligations for market participants

A market participant can be defined as “the manufacturer, authorised representative, importer and distributor”. All market participants who are involved in the supply and distribution chain must take the appropriate measures to guarantee that they place on the market only those PPEs that are in line with this Regulation. This Regulation is intended to guarantee a clear and balanced distribution of the obligations of each market participant in the supply and distribution chain.

What must manufacturers do?

Issue the EU conformity declaration along with the PPE.
A manufacturer may also include a simplified declaration of conformity with the user’s guide, consisting of one sentence and a reference to the web address where the full declaration of conformity can be consulted.
If a product fulfils a combination of EU regulations, such as the PPE, the EMC Directive, etc., then a single EU declaration of conformity must be used.
The technical documentation must be kept for 10 years after the PPE was placed on the market.
Ensure that there are procedures in place to continue to guarantee that the series production is in conformity with this PPE Regulation.
Prepare all the technical documentation referred to in Annex III.
Conduct a risk assessment that takes account not only of the intended use but also of the reasonably foreseeable uses of the PPE (Annex III of the Regulation).

What must manufacturers and importers do?

Conduct sampling of the PPE that is being placed on the market, keep a complaints register and inform distributors of the need for such monitoring.
Name, registered trading name or registered trademark and a postal address where contact can be made or the PPE or the packaging can be reported.
Provide manufacturing instructions for the smallest unit available on the market, in a language that the end users and market surveillance authorities can easily understand.

What must importers do?

Before a PPE can be placed on the market, the importers must ensure that the manufacturer has carried out a conformity assessment procedure.
Ensure that the manufacturer has prepared all the technical documentation required in Annex III.
During ten years after the PPE have been placed on the market, a copy of the EU declaration of conformity must be kept available for the market surveillance authorities and the technical documentation must be available to the authorities upon request.

What must distributors do?

Take the necessary care in bringing a product to market.
Before a PPE is offered on the market, check if it has been given the CE marking, accompanied by the requisite documents and the instructions and relevant information.
Before a PPE is placed on the market, ensure that the manufacturer has carried out a conformity assessment procedure.

Importers and distributors should be prepared to cooperate actively with market surveillance actions.

All three parties should inform the competent authorities if a PPE exhibits a risk and if they consider or have reasons to believe that the PPEs they have offered on the market are not in conformity with this Regulation must immediately take the necessary corrective measures to bring the PPE in question into conformity or, if necessary, to withdraw or recall them from trading.

Cases where obligations for manufacturers also apply to importers or distributors

An importer or distributor shall be regarded as a manufacturer for purposes of this Regulation, and must therefore fulfil all obligations incumbent on manufacturers, if it places a PPE under its own name or trademark on the market or if it makes such changes to PPE already on the market that they can no longer be in conformity with this Regulation.

Advice for employers who buy PPE for their employees

If you are responsible for the purchase of PPE, we advise you to ensure that your PPE suppliers are able to comply with the new Regulation in the same way as is required under the current Directive. It is very difficult for the user to determine whether a product is compliant. We advise anyone concerned by the safety of a PPE that has been delivered, to do the following:

Ask you suppliers for a declaration of conformity for the PPE you are buying. Check them for the legally required information. Many declarations of conformity are incomplete and do not bear the official signature.
Ask your suppliers to describe their sampling process in order to guarantee that the products continue to meet the requisite standards.
Ensure that your suppliers are members of a sectoral organisation .
Ask your suppliers to describe the quality assurance of their production process, in order to ensure that the products are manufactured in accordance with the original certification.

Non-compliance

Be aware the following factors can lead to non-compliance:

Be aware that the following factors can lead to the product being formally non-compliant.
If it bears a CE marking has been affixed contrary to the Regulation.
If the CE marking has not been affixed.
If the identification number of the reported institution involved in the production control stage is incorrect or missing.
If the EU declaration of conformity has not been provided or is incorrect.
If the technical documentation is incomplete or missing.
If the technical information, as referred to under the obligations for manufacturers/importers, is incorrect, incomplete or missing.
If other administrative requirements, such as those referred to in the obligations for manufacturers/importers, have not been fulfilled.

How does Intersafe help?

Although the text of European Regulation 2016/425 has now been published, there is still considerable lack of clarity as to how certain articles should be interpreted in an unambiguous way by all market participants.
we are continually working on the current as well as the future legislation and the appropriate standards for our products and services
We actively participate in working groups of the European Safety Federation (ESF), Nederlands Normalisatie Instituut (NEN), AVAG, Febelsafe and Synampa. These are consultative bodies in which representatives of the European Commission, notified bodies , national governments, manufacturers and distributors participate. Through these working groups and consultatives we keep abreast of the progress and we have an influence on the development of knowledge and information from our industry.
This makes us able to meet in time the requirements under the new PPE regulation. This means that we check all the products we bring to the market if they comply with the new regulations. Where necessary we apply measurements together with the manufacturer.
Of course we will inform you the next time periodically on progress.

Interested?

Please contact us for more information.

Footnotes

Official Journal of the EU: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2016.081.01.0051.01.ENG&toc=OJ:L:2016:081:TOC
For the Netherlands, that means the “Warenwetbesluit Persoonlijke beschermingsmiddelen”.
For the Netherlands, that is AVAG, for Belgium it is Febelsafe and for France, Synamap