24 June 2016
Deadline Approaches for Products Treated with Biocides to Remain on the EU Market
From 1 September 2016, articles treated with a biocide present on the EU market prior to 1 September 2013, will need to have their active substances and product-type authorised by ECHA. In accordance with the Biocidal Products Regulation 528/2012 (the BPR), on 1 September 2016, the transitional period allowing the presence on the EU market of products treated with biocides which contained unapproved active substances, and which were already available on the EU market on 1 September 2013, will expire.
Hong Kong traders may recall that the BPR seeks to address the health and environmental hazards presented by biocides, i.e. the chemical agents capable of killing harmful organisms such as pests and bacteria. The BPR regulates the use and placing on the market of biocidal products whose active substances protect against harmful organisms.
The BPR began to apply from 1 September 2013, and from that date onwards all biocidal products (unless exempted), active substances, and product-types have had to be authorised. The term ‘product-types’ is an umbrella term for the specific use of active substances, such as disinfectants, repellents, and pest control products.
Certain articles (often, commonly used consumer products) are treated with biocides to protect them from the possible harmful effects of organisms such as pests, mould and bacteria. According to ECHA, treated articles include: mixtures, e.g. a paint that contains an in-can preservative; articles, e.g., a sofa with wooden arms which have been treated with preservatives, or a refrigerator treated with substances to prevent mould and odour; and articles that intentionally incorporate a biocidal product.
The latter include textiles, plastic articles, or other goods with an antibacterial hygienic function intended, for example, to inhibit the growth of pathogens or prevent disagreeable odours; mosquito nets treated with insecticides to kill insects; and textiles such as sleeping bags treated with repellents to repel insects.
Since 1 September 2013, applications have been made for the approval of the active substance and product-type of biocides that are used to treat mixtures and articles. ECHA has published on their website a list of active substances, and their product-types, that have been approved or are in the process of approval.
However, applications for approval must be submitted to ECHA by 1 September 2016. Otherwise, from this date, any product treated with a biocide that has not been approved can only remain on the EU market until 1 March 2017. Articles treated with biocides whose active substances are being reviewed by the EU BPR review programme can remain on the EU market pending the outcome of their review.
Hong Kong sellers of consumer goods should be aware that from 1 September 2016, only articles treated with a biocide with an approved active substance and product-type can be placed on the EU market. However, if, after this date, a new active substance is developed, the relevant economic operator can apply at any time for its approval. Articles treated with the new active substance cannot be placed on the EU market unless approved.
It may be of interest to Hong Kong traders to learn that exactly the same rule applies for importers. This is a significant change compared to the previous biocides law, whereby articles imported into the EU could already have been treated with substances that could not themselves be used in the EU. An example of this would be sofas treated with dimethyl fumarate, to protect from mould. Thus, manufacturers and suppliers from third countries must comply with EU law just as in the case of EU manufacturers and suppliers. They must treat their goods solely with active substances or biocidal products that are authorised for use in the EU, if they intend to place them on the EU internal market.
On a different albeit related note, Hong Kong traders of treated articles may like to have a recap of the main provisions for placing treated articles on the EU market. In particular, Article 58 of the BPR, concerning labelling, requires information related to the use of biocides on the label. The specific circumstances for this to become applicable are: (i) where a claim is made by the manufacturer regarding the biocidal properties of the treated article, or (ii) having particular regard to the possibility of contact of the active substance(s) in the treated article with humans or the environment, the conditions associated with the approval of the active substance(s) so require. Under such circumstances, the labelling must provide the following information:
- a statement that the treated article incorporates biocidal products;
- where substantiated, the biocidal property attributed to the treated article;
- names of all active substances contained in the biocidal products;
- names of all nanomaterials contained in the biocidal products followed by the word ‘nano’ in brackets;
- any relevant instructions for use, including any precautions to be taken because of the biocidal products with which a treated article was treated or which it incorporates.
The above need not apply where at least equivalent labelling requirements, which meet information requirements concerning the active substances in biocidal products in treated articles, already exist under sector-specific legislation.
Aside from the abovementioned labelling requirements in only the specific circumstances concerned, any person responsible for placing treated articles on the EU market must label these with any relevant instructions for use, including any precautions to be taken, if necessary, to protect humans, animals and the environment. All labelling must be clearly visible, easily legible and appropriately durable. Suppliers of treated articles shall, if a consumer so requests, provide that consumer, within 45 days and free of charge, with information on the biocidal treatment of the treated article.
For more information, please click on the following:
The Biocidal Products Regulation 528/2012
The Amending Regulation 334/2014