CA-Sept12-Doc.5.1.h
UK comments on treated articles provisions in new Regulation – questions received and a thought starter on responses
The UK CA has received a number of enquiries regarding the scope and application of the provisions in the new Regulation on treated articles. Some of the key questions of interpretation have been discussed already and are being addressed in draft Commission guidance on the treated article vs biocidal products distinction. However a number of the questions we have received raise further issues of interpretation that have not yet been discussed or resolved in the CA forum.
We therefore thought it would be helpful to share these questions with otherMSCAs and to initiate discussion with a view to reaching as consistent an interpretation as possible in advance of the application date of the Regulation.
We have also suggested some answers to the questions based on our initial thinking and welcome further discussion.
Questions on treated articles
General questions
Question 1 – do the requirements for treated articles cover treatments only on the finished article, or treatments of components that were treated further back in the supply chain? If so, how far back in the supply chain do possible treatments have to be identified? E.g. a table is manufactured outside the EU from MDF, and the MDF is bound with glue containing a preservative (also manufactured outside the EU) – does the preservative have to be approved if the table is then placed on the EU market? Or, electrical components within a television were treated with a biocidal active to give them fungicidal properties (and no other part of the TV was treated). Does the active in the fungicide have to be approved?
Suggested answer: The Regulation defines a treated article as ‘any substance, mixture or article which has been treated with, or intentionally incorporates one or more biocidal products’. We interpret this to mean that the treated article provisions apply only if the article itself was treated – meaning that it was treated in the form in which it was imported. It would not apply if the only treatment was to components further back in the supply chain. Such earlier treatments of components would in any case be extremely difficult for both importers and enforcers to identify, especially for complex articles.
Comment - One relevant consideration here is that a similar issue occurs in REACH, where the presence of an identified “substance of very high concern” constituting >=0.1% by weight of a given article triggers duties for the supplier to communicate information down the supply chain (REACH Article 33). Although there are dissenting views, the majority view of Member States is that this requirement applies to the percentage by weight of the substance in the article in the form in which it is imported, and not to its percentage in components of the article. A similar approach here would mean considering treatments to the finished article, and not to its components.
Question 2 – the Regulation says that the active substance in a biocidal product used to treat an article must be ‘approved for that use’ – what does this mean? Does it just refer to the product type?
Suggested answer: provided the active is approved for the relevant product type (i.e. the product type that would cover treatments of the article in question), and there is no specific restriction in the approval Regulation/ Inclusion Directive stating that it may not be used for the type of treatment in question, then the article may be imported in compliance with Article 58.
Question 3 – does Article 95 apply to treated articles, i.e. can an article only be treated with a biocidal product containing an active substance where the supplier has submitted a dossier or a letter of access to ECHA?
Suggested answer: no, the requirements on alternative suppliers in A95 do not apply to substances used only in treated articles – only to substances placed on the EU market in biocidal products, or with the intention of being used in biocidal products.
Question 4 – if an article incorporates a biocidal active substance, but for reasons unrelated to its biocidal activity, must the active be approved if the article is placed on the market?
Suggested answer: no, Article 58 only applies where the article was treated with a biocidal product. This means that the product (and hence the active substance) must have been applied with the intention of exerting a biocidal effect.
Question 5– An article contains residues of a biocidal treatment that was used during the production process on some part of the manufacturing equipment. The treatment was not used on the article itself. Must the active substance in this biocidal treatment be approved if the article is imported? E.g. paper could contain traces of a biocide that was applied as a slimicide to the printing equipment.
Suggested answer: no, a treated article is an article that is “treated with, or intentionally incorporates, a biocidal product”. In this case the biocide is not used to treat the article, and is not intentionally incorporated into the article. Therefore it does not have to be approved when the article is placed on the market.
Questions on labelling of treated articles
Question 6 – A treated article is marketed with a claim that it incorporates an active solely for the purpose of protecting the article. For example, a piece of wood or leather is marketed with a claim that it has been treatedto prevent the wood or leather from rotting. Does this have to be labelled?
Suggested answer: Article 58(3) states that labelling is required where ‘a claim is made by the manufacturer of that treated article regarding the biocidal properties of the article’. In this case, it would be misleading to claim that the article itself has biocidal properties, since the biocidal claim is only that the treatment is to preserve the article in question. This contrasts with a case such as a chopping board claimed to be antibacterial or ‘stay fresh’ socks, where it is claimed that the article has biocidal properties external to itself, so the article would have to be labelled. Therefore, such treated articles would not have to be labelled under the Regulation.
Comment – there is possibly an analogy here with the distinction drawn in guidance under the BPD between treated articles where the biocidal treatment has external, or purely internal, effect (Doc-Biocides-2002/04-Rev3). That is, articles which are intended to control organisms other than those that are only harmful to the article itself, and which are accompanied by a relevant claim, would have to be labelled. However articles where the biocidal treatment is intended only to control organisms harmful to the article itself, even if this is mentioned by the manufacturer, would not require labelling.
Question 7 – where does a biocidal claim have to be made for labelling to be required? For example, an article is marketed without mention of biocidal properties, but it is mentioned in the technical documentation supplied with the article that it has been treated with a biocide for a purpose other than just preservation of the article itself (see Q1).
Suggested answer: the Regulation does not specify where a claim has to be made, so if it is included as part of the technical specifications of an article this would trigger the labelling requirement if a biocidal claim is being made.
Question 8 – where does the label for a treated article have to be placed – must it be affixed to the article itself or can it be placed on instructions or packaging?
Suggested answer: The Regulation provides in Article 58(6) that “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… unless [the] MemberState provides otherwise”. It is a matter of judgement for the supplier whether the label can be placed on the article itself or must be put on the packaging or instructions. (NB some Member States might derogate from these requirements, this would need to be checked with the individual MemberState.)
Questions on transitional arrangements for treated articles
The following answers refer to the current text and are subject to any changes that are agreed to Article 94 of the Regulation.
Question 9 – I market an article that is treated with a biocide containing an active that is currently supported in the review programme for the relevant product type. Can I continue to market it until a decision is taken on the approval/non-approval of the active?
Suggested answer: Yes. This is because Article 94 says that if the article is already on the market on the date of application of the Regulation, it can continue to be placed on the market if the application for approval is submitted by 1 September 2016. In this case the application for approval has already been submitted (so it has been submitted by 1 September 2016). So the article can remain on the market.
Question 10– I market an article that is treated with an active that is not currently in the review programme. I intend (or I know someone else intends) to apply for approval of that active before 1 September 2016. Can I keep the article on the market until the application is submitted?
Suggested answer: Again, subject to any amendments to Article 94 – the article is already on the market so can remain on the market until 1 September 2016. If an application for approval is submitted by that date, the article can remain on the market until a decision is taken on whether to approve the active. In case of a decision not to approve, the article must come off the market within 180 days.
Question 11 – I market an article that is treated with an active that is not currently in the review programme. I understand I can keep it on the market until at least 2016. However I would like to make some changes to the design/ introduce a new article in the range, that will be treated with the same biocide. Is this allowed?
Suggested answer: Provided the changes/new articles do not affect the use and foreseeable exposure and risks from the biocide incorporated into the article, minor changes to the article design/ variants of the article are permissible.
Question 12 – I market an article that is treated with an active that is not currently in the review programme because it was subject to a non-inclusion decision. As far as I know, no new application will be made to support the active. When do I have to remove the article from the market?
Suggested answer: Article 94 says that in case of a decision not to approve an active substance for the relevant product type, treated articles should come off the market 180 days after the decision or 1 September 2016, whichever is the later. In this case the non-inclusion decision has already happened, so the article should be removed from the market on 1 September 2016.
Question 13 – I market an article that is treated with an active that is not currently in the review programme because it was never identified or notified (it has never been used in biocidal products in the EU). As far as I know, no-one is going to support the active now. When do I have to remove the article from the market?
Suggested answer: Article 94 allows the article to remain on the market until 2016. Because it has never been in the review programme there will be no non-inclusion decision. Therefore, if no application is made for approval, it must be removed from the market on 1 September 2016 according to Article 94(2).
UKCA
30 August 2012