On September 1st, 2013, the Biocidal Products Regulation (EU) 528/2012 replaced the previous Biocidal Products Directive 98/8/EC. A major change is that articles which have been treated with a biocidal product are now also regulated.
The inclusion of ‘treated articles’ has an impact on many products. Manufacturers may not be aware of the additional obligations that have become applicable to their products.
Biocides kill or repel organisms like bacterias, moulds, pests and insects. The complete definition is “biocidal products have the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action”.
The definition of a treated article in the Biocidal Products Regulation is: “any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products”.
Treated articles may be recognised by claims such as anti-bacterial, anti-microbial, anti-odour, anti-septic, anti-fungal, anti-mould, preservation, conservation, disinfectant, anti-fouling or insect-repellent.
IMPORTANT NOTE: if the biocidal function (e.g. anti-bacterial) is the primary function of
the product - the product is considered a biocidal product under the regulation, and not a treated article.
However also products without these claims could be considered treated articles, for example if they have been treated with biocides to protect the properties or function of an product or extend its durability.
1. Approved active substances
Treated articles should only contain or been treated with active substances that are approved by the EU.
The ECHA website contains a list of approved biocidal active substances.
It is important to check if the approval is valid for the product-type and use; and also if the treated article has to comply with any conditions or restrictions related to the approval of the active substance.
2. Labelling obligations
Information about the treated article and its biocidal properties must be mentioned on the product label in the following two cases:
A (marketing) claim is made regarding the biocidal function of the product
This could be a statement that the treated article has a certain degree of protection against unwanted organisms or that the treated article has a certain efficacy or action against unwanted organisms. When a claim is made, the efficacy must be substantiated (evidence).
Approval conditions of the active substance
For some active substances - particularly if there is a possibility of contact with humans or release into the environment - the conditions associated with the approval of the active substance may require labelling of the treated article.
The label shall provide the following information in the national language: • A statement that the treated article incorporates biocidal product(s);
The labelling should be clearly visible, easily legible and appropriately durable.
Where necessary because of the size or the function of the treated article, the labelling shall be printed on the packaging, on the instructions for use or on the warranty in the national language.
3. Other obligations
Similar to REACH there is an obligation to provide information on biocidal treatment of the article at the request of a consumer within 45 days and free of charge.
An exemption is made to all goods stored in a premise or transported in a container, which was fumigated or disinfected; on the condition that no residues would be expected to remain from the fumigation
The European Commission issued a draft guidance document with frequently asked questions on treated articles in December 2014.
You can download the document here. Please note that there has been no official endorsement in the EU for this guidance document, national authorities might deviate and enforce a different interpretation.
A survey by Swedish authorities showed that there is a large amount of consumer products that are treated with biocides.
A handbag made from (treated) leather is also a treated article itself, a wooden table with a preservative in the paint or glue too.
Socks, clothes, sportswear, underwear, rainwear, hats, gloves, home textiles, mattresses and covers, pillows, beddings, towels, rugs, curtains.
Shoes, insoles, clothes, belts, bags, purses, decorations, accessories, furniture.
Wooden tables, chairs, closets, bed boards, upholstery.
Floor and wall coatings, fabric wall coverings, ceramic tiles, insulation materials, knobs and handles, paints.
Chopping boards, food boxes, cutlery, bowls, plates, sinks, dish brushes, plastic bags, garbage bags.
Shower hoses, tiles, bathtubs, toothbrushes, shower curtains, bath mats, toilet paper, toilet lids, personal hygiene products, cat litter.
Cleaning cloths and mops, sponges, tissues, washing balls.
Stationery, pencils, stamps.
Keyboards, computer mice, calculators, headsets, phone accessories.
Teddy bears, feeding bottles, napkins, changing stations, diapers.
Vacuum cleaners, water heaters, refrigerators, dishwashers.
Sofa with anti-mould
A sofa that has been treated with a fungicide to prevent growth of mould during shipping, is that sofa to be regarded as a treated article?
Yes. It has been treated with a preservative in order to prevent deterioration of the sofa. This function is intended and remains a property of the sofa, regardless of whether the sofa is placed in conditions where mould can grow or not. The sofa is a treated article.
Glue in composite wood
A table is manufactured from composite wood, and the wood is bound with glue containing an in- can preservative. Does the preservative have to be approved as an active substance and is the table then a treated article?
No, the preservative was used to preserve the glue during storage, but not after its use to make the composite wood and the finished table.
Television without fungi
Some electrical components within a television were treated with a biocidal product to give them protection against the growth of fungi (and no other part of the TV was treated). Does the active substance in the fungicide have to be approved in the EU?
Yes, the protection against fungi is intended to be effective in the finished television set. The TV then is considered to be a treated article, and the active substance must be approved.
A leather handbag
A handbag is manufactured from leather that has been treated with a biocide to protect it from harmful organisms during and after production.
Is the handbag a treated article?
Yes, even if only a small part of of the finished good has been treated but the treatment has an intended biocidal function in the finished good, then the entire product is a treated article.
A floor with a claim
A company uses in marketing the argument that their product has a coating that inhibits bacterial growth. What is the consequence?
In all cases where a claim concerning a biocidal function of a finished good is made, it is evident that the presence of a biocidal active substance in the finished good is intended by the manufacturer. Such goods will always be considered treated articles (unless they are a biocidal product themselves).
For more information on biocidal and chemical products browse the website of the European Chemicals Agency (ECHA): echa.europa.eu.