Personal protective equipment

Obligations of businesses

In addition to product requirements, there are statutory obligations for economic operators, i.e. the manufacturer, authorised representative, importer, distribution service provider and distributor of the PPE.

• Manufacturer refers to a business that manufactures a PPE, or has it manufactured, and markets it under its name or trademark. The manufacturer of the PPE is responsible for ensuring that it is safe and compliant. The manufacturer must carry out all the conformity assessment procedures relating to the PPE, draw up the required documents and affix the necessary markings to it. The manufacturer’s obligations are listed in Article 8 of the PPE Regulation.

• Authorised representative refers to a business established within the EU that has received a written mandate from the manufacturer to act on their behalf in relation to specified tasks. The authorised representative’s obligations are listed in Article 9 of the PPE Regulation.

• Importer refers to a business established within the EU that places a PPE imported from a third country on the EU market. The importer must ensure that the manufacturer has fulfilled their obligations regarding the assessment of the PPE’s conformity, drawn up the required documentation, and affixed the necessary markings. The importer is responsible for ensuring that the PPE complies with the European requirements and any specific national requirements. The importer’s obligations are listed in Article 10 of the PPE Regulation.

• Distributor refers to a business in the supply chain other than the manufacturer or the importer who makes a product available on the EU market. In other words, distributor refers to a business that sells PPE manufactured in the EU or that has previously been placed on the EU market. Distributors include retailers and wholesalers of PPE. The distributor must check that the PPE bears the required markings, and that the required documents, instructions and safety information in Finnish and Swedish have been provided with the PPE. The distributor’s obligations are listed in Article 11 of the PPE Regulation.

According to EU legislation, an economic operator importing PPE to Finland can be either an importer (importing PPE from a third country) or a distributor (importing equipment from the EU market). You can find more information on the obligations of economic operators on the Tukes website.

Online store

Remote sales is a trade in which the buyer and the seller are not simultaneously present. Online stores are typical examples of remote sales. The product’s delivery method is not relevant in remote sales. It is also considered remote sales even if the product is picked up from the store, if the actual purchase contract is made remotely. Remote sales have exceptions in comparison to normal trading. You can find more information on the rules of remote sales, such as advance information, on the website of the Finnish Competition and Consumer Authority.

The statutory requirements for PPE are the same, regardless of where they are sold. However, in an online store, PPE and its packaging are not physically viewable, so the sellers of online stores must provide information relevant to the safe use of the PPE when it is sold. PPE can be considered dangerous or non-compliant based on the information provided in the online store alone if the information provided is incorrect, or if the advertising is non-compliant.

You should acknowledge the following matters at least:

1. The online store must provide information relevant to safety and/or purchasing decisions: Consumers must be able to determine whether they can use the PPE safely.

2. Product information must not be misleading (e.g. a product that is not a reflector must not be sold as a reflector)

3. The information to be provided includes:

• Warnings
• Information relating to choosing the right size of PPE

4. Restrictions on use or deployment

Private label/Own brand

Private label refers to a product that a business markets under its name or trademark, even if the product was originally manufactured by another company. Sometimes such a business calls itself a “commissioner”, but from a legal point of view, the business is the manufacturer. As the business is the product’s manufacturer, it is subject to all the manufacturer’s responsibilities. The business cannot delegate responsibility for the conformity of the product. Instead, it must be familiar with the product’s characteristics and manufacturing process, as well as own the documentation that demonstrates the conformity of the product.

The importer or distributor is considered to be the manufacturer when

• the PPE is placed on the market under its own name or trademark
• PPE that has already been placed on the market is altered in a manner that may affect the compliance with the applicable requirements.

Product’s non-conformity

All economic operators, manufacturers, importers and sellers are responsible for the conformity of the PPE. Placing PPE on the market does not require inspection or approval by the surveillance authorities. However, a market surveillance authority may assess the conformity of the PPE placed on the market. For example, it may test it or request the businesses to provide it with the EU declaration of conformity, technical documentation, and other information.

If the business suspects that the PPE it has placed on the market is not in conformity with the requirements, it must immediately take steps to bring the PPE into conformity, withdraw it from the market, or arrange a return procedure when necessary. If the properties of PPE present a risk to safety, health or the environment, the business must immediately contact the authorities of the member states in which the product has been on the market, giving details on the non-compliance and of any corrective measures taken.