Biocidal treated articles
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 treated article is an article that is treated with a type of pesticide, called a biocidal product. The aim of the treatment is to give the article a function, for example to make sportswear odourless or a cutting board antibacterial. Other examples of articles that may be treated with biocidal products are building materials, boats painted with antifouling paint, impregnated wood, shoes, mattresses, cleaning supplies, and household appliances.
Articles that are treated with biocidal products contain substances that can be dangerous or toxic to humans and the environment. Therefore, articles may only be treated with allowed substances to be placed on the market and sold in the EU, according to the EU-regulation on biocidal products.
The European Commission has published a guidance document on treated 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 that is treated with a biocide can be a biocidal product
Sometimes biocides are used to treat articles against viruses, bacteria, fungus and insects. It is important to remember that when such treatment is to protect the user against infestation, there are strong reasons to assume that the biocidal function is the main function of the product. If so, the article will be considered as a biocidal product which may need to be authorised before it can be made available on the market.
You must be able to prove that the product has the effect that is claimed in your marketing. If you make claims against for example a virus, it is always a claim to protect a person, not the article or the material. Even with claims such as antibacterial, antimicrobial, etc., there are strong reasons to assume that it is the user that should be protected. The same applies for many articles that are treated with insecticides or repellents.
Depending on the marketing, a treated article may also be considered as a medicine or medical device, for example if you have a claim for protection or cure for a disease. If so, it is the Medical Products Agency that is the responsible authority.
Rules for manufacturers and importers
As responsible for the article, you need to ensure that the article is treated with an active substance that is allowed in the EU. This applies to articles manufactured in the EU as well as articles imported to be sold within the EU. In addition, articles manufactured within the EU can only be treated with allowed biocidal products.
An active substance is allowed in the EU if it is approved for the right product type and use. During a transition period, a substance is also allowed if it is under evaluation and is included in the EU review program 1062/2014. You can find out the status of an active substance by searching the European Chemicals Agency, ECHA's database.
ECHA has established a list of active substances in combination with product type that are permitted in biocidal products. You can find the list here External link..
You can also find out the status of an active substance yourself by searching the European Chemicals Agency's ECHA database of active substances External link..
A biocidal treated article must be labelled with clear and easily understandable information. This applies to all articles which are:
- sold with a claim that the article has a specific function and
- treated with an active substance that require labelling according to the approval of the substance.
The treated article should also be labelled with relevant instructions for use, including precautions, if this is necessary to protect humans, animals and the environment.
If the articles are manufactured in the EU, the manufacturer is responsible for the labelling. If the articles are imported into the EU, the importer is responsible.
The label must be in the official languages of the Member State where the article is sold, hence such information must be in Swedish if the article is sold in Sweden. The labelling shall provide information that states:
- that the article contains a biocide
- the active substances contained in the product
- the purpose of the treatment, thus how the active ingredients contribute to the article's function
- relevant instructions and precautions, if any, for example if the user of the article should do anything special to protect people or the environment
- any nanomaterials in the biocidal product. Nanomaterials are extremely small particles that can be included in biocidal products and shall in that case be named on the article.
Your company must provide information about the biocidal treatment of the article to any consumer asking for it. The information shall be provided free of charge, within 45 days. You must also be able to show that the biocide has the intended effect.
Rules for the distributor
If you are selling a biocidal treated article, you must verify that the articles are properly marked. Be observant if an article is described as "odourless" or "antibacterial". This could mean that the article must be labelled. If you do not know if the article is treated or not, contact your supplier or the manufacturer of the article. They are required to give you the information you need.
The purpose of labelling is to inform consumers that the article contains substances that can be harmful and how to use it safely for the health and the environment.