An important and strictly regulated product group in the area of product safety in the Netherlands and in the EU is personal protective equipment. Personal protective equipment (PPE) is defined as products that a user can wear or hold in the workplace, at home or during leisure time to protect against risks to their health or safety such as contamination or noise. In times of the COVID-19 pandemic, many people came into contact with this product group because they wore a so-called FFP2 mask. In Germany, for example, these FFP2 masks were even mandatory. Other examples of personal protective equipment include safety shoes, head, and ear protection but also protective (work) clothing. As the purpose of personal protective equipment is to protect the wearer, specific legal requirements apply to personal protective equipment to ensure this protection.
Martin Krüger, one of our Dutch lawyers specialized in Product Compliance, has already written a blog about mouth-covering masks and CE marking. In this article, Our Dutch lawyers for Product Compliance Martin Krüger and Claartje van der Marel will discuss the general legal requirements for personal protective equipment.
Occupational Health and Safety Act sets out requirements for personal protective equipment
The legislation surrounding personal protective equipment is also essential within the framework of the Working Conditions Act and the requirement for a safe working environment to be provided. The Working Conditions Act sets requirements for personal protective equipment and stipulates that an employer must provide personal protective equipment that meets the requirements of the Commodities Act Decree on Personal Protective Equipment 2018.
Regulation (EU) 2016/425
The Commodities Act Decree on Personal Protective Equipment is based on European legislation, namely Regulation (EU) 2016/425 (‘PPE Regulation’). The PPE Regulation lays down the requirements for the design and manufacture of personal protective equipment. Based on the PPE Regulation, personal protective equipment must also have a CE marking before it may be traded in the European Economic Area (‘EEA’).
Definition of personal protective equipment
An important first step is to examine whether a product falls under the definition of personal protective equipment (PPE) according to the PPE Regulation. The PPE Regulation defines personal protective equipment as follows:
- Equipment worn or held by a person for the purpose of protecting against one or more risks to his/her health or safety;
- interchangeable parts for an item of equipment that are essential for the protective function;
- connection systems for an item of equipment that is not carried or held by a person and that is intended to connect the equipment to an external device or a reliable anchorage point, which is not designed to be permanently attached and does not need to be fastened before use.
It is important to note that not all PPE falls within the scope of the PPE Regulation and exceptions are included in the legislation. For example, the PPE Regulation does not apply to PPE designed specifically for use by the armed forces or for law enforcement purposes.
The PPE Regulation does apply to personal protective equipment within the meaning of the PPE Regulation that is new in the market in the EEA or imported from a country outside the EEA. This includes new products produced by a manufacturer established in the EEA and new or second-hand products imported from a country outside the EEA. The PPE Regulation aims to ensure and improve the health and safety protection of users of personal protective equipment.
Essential health and safety requirements for personal protective equipment
Personal protective equipment must meet the safety requirements of the PPE Regulation. To this end, the PPE Regulation sets out so-called essential health and safety requirements for personal protective equipment. Personal protective equipment must be designed and manufactured in accordance with the essential health and safety requirements applicable to the product. Only if the essential health and safety requirements are satisfied may an item of personal protective equipment be CE marked and placed on the market in the EEA.
To meet the essential health and safety requirements, so-called harmonised standards have been developed, which provide guidance on how to meet the specific requirements for safety for personal protective equipment. The standards applicable to your situation can be consulted in the Netherlands at the Dutch standards institute (NEN). When the personal protective equipment complies with the applicable harmonised standards, there is a presumption of conformity with the essential health and safety requirements for personal protective equipment according to the PPE Regulation.
The essential health and safety requirements that an item of personal protective equipment must meet depend on the risks it is intended to protect against. The PPE Regulation defines three different risk categories into which a product can fall:
- minimal risks;
- risks other than those mentioned in I and III;
- risks that can have very serious consequences.
The classification of a product in the appropriate risk class is essential for determining the obligations and requirements under the PPE Regulation. Examples of Category 1 personal protective equipment are PPE which protect against minimal risks such as superficial mechanical injury, contact with relatively innocuous cleaning agents or prolonged contact with water, contact with hot surfaces not exceeding 50°C or damage to the eyes caused by exposure to sunlight (other than during observation of the sun). Examples of personal protective equipment from risk class I are sunglasses, rainwear, and simple gardening gloves.
Category 2 covers all personal protective equipment against medium risks, which is not included in categories 1 and 3. The majority of personal protective equipment falls under Category 2 for example safety shoes or safety helmets.
Personal protective equipment in Category 3 must protect against hazards that can have very serious consequences and that cannot be reversed. Such personal protective equipment must, for example, protect against substances and mixtures that are hazardous to health, ionising radiation, hot environments with effects similar to those of an air temperature of at least 100 °C, cold environments with effects similar to those of an air temperature of – 50 °C or less, falls from a great height, cuts caused by chainsaws, and also harmful noise.
Personal protective equipment with CE marking
Personal protective equipment as defined in the PPE Regulation must be CE marked. The Commodities Act Decree on Personal Protective Equipment also prescribes PPE with a CE marking. The CE marking must be affixed to the product itself. If this is not possible, the CE marking must be affixed to the packaging and to the documents accompanying the product.
For Category 1 personal protective equipment, the manufacturer affixes the CE mark himself after having assessed the level of protection of a product by means of an internal control. For personal protective equipment that falls under Category 2 or 3, approval by a Notified Body is required for the CE marking. This is a body designated by a member state of the European Union, which may, under a certain directive or regulation, carry out the relevant tests required under the legislation and regulations before the product is placed on the market. A list of Notified Bodies appointed under specific legislation is published by the European Commission in the NANDO database.
Market surveillance of personal protective equipment
In the Netherlands there are two supervisory authorities that deal with the market supervision of personal protective equipment. The Dutch Food and Consumer Product Safety Authority (‘NVWA’) supervises compliance with the PPE Regulation for consumers. The Inspectorate SZW is the supervisor of personal protective equipment for professional users and ensures that companies operating in the Netherlands also comply with the Commodities Act Decree on Personal Protective Equipment 2018. In this law, the rules, standards, and regulations that follow from the PPE Regulation are implemented.
Lawyer in the Netherlands for personal protection equipment
Our Product Compliance lawyers at MAAK Advocaten in Amsterdam will be happy to advise and support you in determining which legal requirements for Personal Protective Equipment (PPE) apply in your case and how you can meet them, but also in disputes with competitors or discussions with regulators. Our lawyers are regularly confronted with legal issues concerning the legal requirements for personal protective equipment and have extensive knowledge and experience in this matter.
Dispute or advice in the Netherlands on Personal Protective Equipment
The Dutch lawyers at MAAK Advocaten in Amsterdam have extensive experience in assisting companies in the manufacturing industry with various Product Compliance issues. Would you like to get legal advice on the applicability of the PPE Regulation or on the obligations for personal protective equipment? Does your company have to deal with an enforcement issue by the NVWA or Inspectorate SZW? Or do you need support in a dispute with another market participant? Please contact Martin Krüger or Claartje van der Marel or one of our other Product Compliance lawyers.
Contact Person: Martin Krüger and Claartje van der Marel | Attorney at law and Product Compliance specialist