Personal Protective Equipment Regulation
Table of Contents
- The Regulation: PPE Regulation (EU) 2016/425
- Path to EU Market Entry
- The Transition to the New Regulation (EU) 2016/425
- Personal Protective Equipment Directive 89/6866/EEC
- Authorized Representative
- Post-Market Surveillance
- Risks of Non-Compliance
Per the Personal Protective Equipment (PPE) Regulation (EU) 2016/425, PPE is defined as:
a. equipment designed and manufactured to be worn or held by a person for protection against risks to that person’s health or safety;
b. Interchangeable components for equipment referred to in point (a) which are essential for its protective function (e.g. filters);
c. 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
The PPE Regulation applies to all sorts of PPE being placed on the EU market except for those:
a. specifically designed for use by the armed forces or in the maintenance of law and order;
b. designed to be used for self-defense, with the exception of PPE intended for sporting activities;
c. designed for private use to protect against:
i. atmospheric conditions that are not of an extreme nature,
ii. damp and water during dishwashing;
d. exclusively used on seagoing vessels or aircraft;
e. designed to protect head, face or eye as helmets and their visors used by drivers and passengers of motorcycles and mopeds.
The Regulation: PPE (EU) 2016/425
The new Regulation (EU) 2016/ 425 (PPE Regulation) of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating personal protective equipment is fully entered into force on the 21st of April 2018 replacing the Personal Protective Directive 89/686/EEC. The PPE Regulation comes into full effect from 21st April 2019.
The PPE Regulation ensures that all personal protective equipment provides a high level of protection of the health and safety of users.
Therefore, the PPE Regulation lays down common standards to provide adequate protection against the risks which is intended to protect.
- Chapter I: General Provisions (art.1-7)
- Chapter II: Obligations of Economic Operators (art.8-13)
- Chapter III: Conformity of PPE (art.14-17)
- Chapter IV: Conformity Assessment (art.18-19)
- Chapter V: Notification of Conformity Assessment bodies (art.20-36)
- Chapter VI: Union Market Surveillance, Control of PPE entering the Union Market and Union Safeguard Procedure (art.37-41)
- Chapter VII: Delegated and implementing acts (art.42-44)
- Chapter VIII: Transitional and Final Provisions (art.45-48)
- Annex I: Risk categories of PPE
- Annex II: Essential Health and Safety requirements
- Annex III: Technical Documentation for PPE
- Annex IV: Internal Production control
- Annex V: EU Type-examination
- Annex VI Conformity to type based on Internal Production Control
- Annex VII: Conformity to type based on internal production control plus supervised product check at random intervals
- Annex VIII: Conformity to type based on Quality Assurance of the Production Process
- Annex IX: EU Declaration of Conformity
- Annex X: Correlation table
Path to EU Market Entry: Compliance
There are defined three categories of equipment based on the risk against which the equipment is intended to protect users.
Category I – Minimal risk
In this category, the PPE is designed to protect people from minimal risks:
a) Superficial mechanical injury;
b) Contact with cleaning materials of weak action or prolonged contact with water;
c) Contact with hot surfaces not exceeding 50°C;
d) Damage to the eyes due to exposure to sunlight (other than during observation of the sun);
e) Atmospheric conditions that are not of an extreme nature.
Category II – Intermediate Risk
This category covers risks other than those defined by neither Category I nor Category III
Category III – Serious Risk
The PPE designed to protect people from risks that may cause very serious consequences such as death or irreversible damage to health:
- Substances and mixtures which are hazardous to health (carcinogenic, mutagenic, reprotoxic, toxic, irritant or sensitizing)
- Atmospheres with oxygen deficiency
- 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
- Harmful biological agents
- Cuts by hand-held chain-saws
- High-pressure jets
- Bullet wounds or knife stabs
- Harmful noise
Each risk category of PPE must comply with clearly defined conformity assessment modules prior to being placed on the market.
PPE covered by categories II and III requires the product to be certified by a Notified Body (NB). The Notified Body will issue an EU type-examination certificate following successful evaluation of a manufacturer’s technical file and independent testing report.
PPE shall meet certain health and safety requirements (Annex II) to not endanger person and properties as those:
- general requirements applicable to all PPE, such as ergonomics, absence of inherent risks and other nuisance factor and manufacturer’s instructions and information
- requirements specific to certain types of PPE, such as PPE subject to ageing or PPE for intervention in very dangerous situations
- requirements specific to particular risks, such as protection against mechanical impact or in liquids or against ionising and non-ionising radiation.
PPE which is in conformity with harmonized standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the essential health and safety requirements set out in Annex II covered by those standards or parts thereof.
The manufacturer compiles the technical documentation, which makes it possible to assess whether the PPE equipment complies with the requirements of the Regulation. It contains at least the elements set out in the Annex III.
The non-compliance with the Regulation’s requirements will result in the removal of the equipment from the market and the revoke of the CE marking affixed on it.
The Transition to the New Regulation (EU) 2016/425
The PPE Directive 89/686/EEC is repealed with effect from 21 April 2018. The PPE Regulation (EU) 2016/425 shall apply from 21 April 2018. As of 21 April 2018, manufacturers can place PPE on the European market which are compliant with the PPE regulation.
The article 47 of Regulation 2016/425 foresees a specific transitional regime for PPE:
- PPE designed and manufactured in accordance with Directive 89/686/EEC can still be placed on the market until 21 April 2019, and in principle EC type-examination certificates in accordance with Directive 89/686/EEC can be issued until the end of the transitional period, unless the classification of the product and/or the essential safety requirements applicable to it have changed (in the new Regulation).
- PPE may be placed on the market after 21 April 2019 and no later than 21 April 2023 on the basis of an EC type-examination certificate and/or an approval decision in accordance with the PPE Directive. This is not applicable in the following cases:
- Higher classification in the Regulation (after 21 April 2019)
- Updated version of the Harmonized Standard may result in a non-compliance of the product with the new Regulation
- Change in design and/or manufacture of the PPE
Personal Protective Equipment Directive 89/6866/EEC
PPE Directive 89/686/EEC (Personal Protective Equipment Directive) was published on June 1995 and covers Personal Protective Equipment (PPE). It is defined as “any device to be worn or held by an individual for protection against one or more health and safety hazards”.
89/686/EEC concerning Personal Protective Equipment (PPE) has 17 Articles and 6 Annexes. Originally published in 1989, the PPE directive only has three modifications 93/95/EEC, 93/68/EEC, and 96/58/EEC.
The introduction establishes the focus of the directive as “safeguarding of public health, improving safety at work and ensuring user protection” and reinforces the European Commissions continuing efforts to create free movement of goods in the European Economic Area through the use
of harmonized standards.
The directive divides PPE into 3 categories; class 1 – simple, class 3 – complex and class 2 – neither of these. For classes 1 and 3 there are comprehensive lists of equipments covered; any equipment not included on either list are classed in the second category. There is also a comprehensive list of equipment excluded from the directive. There are general requirements for all 3 classes, including technical documentation, a CE mark and a Declaration of Conformity. For classes 2 and 3 there are additional requirements.
Awareness and communication continue to be major problems across the EU for the smooth implementation of the directive. Some of the problems identified are:
- Scope: unclear about applicability to consumer PPE for domestic use; also demarcation between PPE and other directives, e.g. Medical Devices and Toys require clarification.
- Standards: still not available for all PPE
- Product Categorization/Conformity
- Assessment Procedures: require clarification to allow an increased scope for self-certification in order to ease demands on third-party testing and reduce compliance costs
- Notified Bodies: greater transparency and uniformity is required across member states in the assessment of applicants for Notified Body status in order to increase confidence in their appointment and activities
At the discretion of the manufacturer, an Authorized Representative may be appointed by written mandate to undertake such activities as:
- Keeping the Declaration of Conformity and the technical documentation available to the Competent Authorities at all times and for 10 years after the equipment is placed on the market
- Accommodate any reasoned requests from the Competent Authorities relating the documentation or conformity of the pressure equipment
- Cooperate with the Competent Authorities regarding and actions to be taken to eliminate and risks relate to the pressure equipment for which they are responsible under the mandate
The Authorized Representative should be clearly identified on the packaging to ensure efficient communication from end-users and EU economic operators in regards to the product(s) compliance.
The authorized representative may not draw up technical documentation as referred to in Article 6(2).
It is the responsibility of each brand owner to continue to collect information related to use of their products after they have been made available to consumers as well as to ensure that they continue to comply as the legislation applicable to their products evolves.
Post-Marketing surveillance activities include, but are not limited to:
- Staying up-to-date on new requirements or legislative changes
- Continual updating of the technical file as modifications are made to the product
- Reporting of any incidents related to the product use
- Removal of non-compliant batches from EU economics operators and end-user
- Keeping technical file available for 10 years after the last batch entered the EU market
Working with a professional Authorized Representative will help to ensure that the necessary actions are taken to ensure continued compliance and proper post-market surveillance.
Risks of Non-Compliance
Evidently, non-compliant products enter the EU Market everyday - whether the brand owner knowingly does so or due to a lack of knowledge imparted from EU importers/distributors.
As there is no "approval" in the EU Market (in most cases), Competent Authorities focus almost exclusively on conducting systematic surveillance of products which are being made available on the market. This can include pulling products off of shelves, stopping products at customs or even deploying bots online to identify non-EU based e-commerce shops which mention that they ship to the EU Market.
Should you choose to take the risk to ship product to Europe which has not followed the required path to compliance as detailed above, you should also be prepared for the consequences.
The main consequences include, but are not limited to:
- Being publicly reported to the RAPEX
- Warehousing Fees
- Requested Withdrawal
- Mandated Withdrawal
- Product Recall (from end-users and/or the market)
- Complete ban on marketing of the product
- Destruction of the product
- Revocation of the CE Marking
Ultimately, the prescribed actions that are to be taken in the case that a product is found to be non-compliant will vary depending on the EU Competent Authority which identified the breach, the EU Member State, cooperation from the brand owner and the actions taken by the appointed Authorized Representative. Above all else, the professionalism and expertise of the appointed Authorized Representative in dealing with various Competent Authorities and handling such situations play a vital role in the successful recovery of your brand in the EU Market.
Looking to export your Personal Protective Equipment to the EU Market? Obelis can support you every step of the way.Get in touch