Biocidal treated articles

Content:

Are you responsible for the import, manufacture or sale of an article that is treated with a biocidal product? You can read about the EU rules that apply to biocidal treated articles here.

A biocidal product is an article that has been treated with a type of pesticide, known as a biocide. The purpose of the treatment is to give the product a function, for example to make a sports shirt odorless or a cutting board antibacterial. Other examples of goods that may be treated are building materials, boats painted with boat antifouling paint, impregnated timber, shoes, mattresses, cleaning materials, white goods, kitchen utensils, cushions, drinking water filters, facade paint, cutting fluids, refrigerators/freezers, etc.

Articles treated with biocides contain substances that can be dangerous or toxic to humans and the environment. Therefore, according to the EU Biocidal Products Regulation, articles must only be treated with permitted substances to be allowed on the market and sold in the EU.

The European Commission has produced a guidance document on biocidal articles, in the form of frequently asked questions and answers. You can find the guidance document on the European Commission's website (CA-Sept13-Doc 5.1.e (Rev1) - treated articles guidance.doc). External link.

An article treated with a biocide may be a biocidal product

Biocides are sometimes used to treat articles against viruses, bacteria, fungi or insects. It is important to remember that when such treatment is carried out to protect the user against infestation, there are strong reasons to assume that the biocidal function is the primary function of the article. In this case, the product will be considered as a biocidal product and may therefore need to be tested and authorised before it can be made available on the market.

The effect of the articles is important

You need to be able to show that a treated article has the effect you claim in your marketing. If you make claims against viruses, for example, it is always a claim to protect humans, not the article or material. Even when it comes to claims such as antibacterial, antimicrobial, etc. there are strong reasons to assume that it is the user who should be protected, not the article itself. The same is true for many articles treated with insecticides or repellents. It is therefore very likely that the article is to be considered as a biocidal product and not a treated article in these cases.

Other legislation may apply

Depending on the marketing, a treated article may also be considered a medicinal product or a medical device, for example if it has a claim of protection or cure against disease. In such cases, the Swedish Medical Products Agency is the responsible authority.

Rules for manufacturers and importers

Manufacturers and importers of biocidal products are responsible for ensuring that their articles are treated only with active substances permitted in the EU. This applies both to articles manufactured in the EU and to articles imported for sale in the EU. In addition, articles manufactured in the EU must only be treated with permitted biocidal products.

An active substance is allowed in the EU if it is authorised for the correct product type and use. During a transitional period, a substance is also permitted if it is under evaluation for the correct product type and is included in the EU review programme EU No 1062/2014 or if an application for authorisation for the correct product type has been submitted in time to ECHA (the European Chemicals Agency) under the transitional provisions of the EU Biocidal Products Regulation EU No 528/2012 (Article 94).

ECHA has established a list of active substances in combination with product type that are permitted in biocidal articles. Please note that the list is not legally binding and that you should always check the status of active substances in accordance with the EU Biocidal Products Regulation.

You can find the list here. External link.

You can find out the status of an active substance by searching the ECHA database of active substances. You may also need to ensure that the intended usage is permitted under the conditions of the authorisation of the active substance.

You can find the ECHA database of active substances here. External link.

Proving the benefit of the biocidal treatment

According to the EU Biocidal Products Regulation and the Swedish Marketing Act, claims for biocidal properties cannot be made unless their effectiveness has been tested and proven. A manufacturer who is going to place a treated article on the market and claims that the article has certain biocidal properties must be able to substantiate such claims. Without benefit and efficacy, it is unnecessary to take the risks to health and the environment that are often associated with biocides.

Labelling requirements

A biocidal product must be labelled with clear and legible information. This applies to all articles

• where the manufacturer claims that the article has a specific function or,
• which are treated with an active substance that requires an authorisation of the substance.

The treated article must also be labelled with the relevant instructions for use and precautions if these are necessary to protect humans, animals and the environment.

If the articles are manufactured in the EU, the manufacturer is responsible for labelling. If the articles are imported into the EU, the importer is responsible.

The labelling must be in the official languages of the Member States where the articles are sold, for example, the information must be in Swedish if the articles are sold in Sweden. The labelling must provide information on

• that the article contains a biocidal product
• the active substances contained in the product
• the purpose of the treatment, i.e. how the active substances contribute to the functioning of the articles
• relevant instructions for use and any precautions, such as whether the user of the articles should take any special measures to protect people or the environment
• any nanomaterials in the biocidal product. Nanomaterials are extremely small particles that may be present in biocidal products, in which case they should be labelled on the articles.

If the treated article is itself a chemical product, the labelling rules for chemical products also apply.

Read more in the EU Biocidal Products Regulation, Article 58. External link.

Informing consumers

Your company must provide information on the biocidal treatment of articles if a consumer requests it. This information must be provided free of charge, within 45 days. You must also be able to demonstrate that the biocidal treatment has the intended effect.

Rules for distributors

If you sell an article treated with a biocide, you must check that it is labelled correctly. If an article is described as ‘odourless’ or ‘antibacterial’, this may mean that it needs to be labelled. If you don't know whether the article is treated in any way, contact your supplier or the manufacturer of the article. They are obliged to give you the information you need.

The purpose of labelling is to inform consumers that the articles contain substances that may be harmful and how to use them safely for health and the environment. As a distributor, you are also obliged to provide information on the biocidal treatment of an article if requested by a consumer, free of charge and within 45 days.

More about biocidal treated articles on ECHA’s website. External link.

Risks of biocidal products

Biocidal products usually act by being dangerous to one or more target organisms. An article treated with biocides is then protected against infestation. However, biocides can also be dangerous to other organisms as well as to humans. It is therefore important that biocides are not used to treat articles unnecessarily or inappropriately. If biocides are increasingly used and released in increased quantities in waste or water, this can lead to concerns for the environment and indirectly for humans.

Their use may also contribute to bacteria becoming resistant to agents that are necessary for hygiene and health in other contexts. For example, there are suspicions that some biocides may render antibiotics ineffective, making it more difficult to cure infectious diseases.