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Biocidal Product Regulation

EURATEX Comments to Note for Guidance CA-Dec12-Doc.5.1

Frequently Asked Questions on Treated Articles

Euratex welcomes the progress made so far on the draft guidance however; many areas still need further improvement to be from one hand, consistent with the legal text and from the other, to bring the necessary clarity needed to facilitate the implementation of the Regulation. To this end, Euratex is of the following opinion:

  1. Euratex fully agree that traceable information concerning biocidal products used in treated articles is an asset however from the draft guidance it is not clear how to evaluate a “primary function” of an article to the extent that it becomes misleading by providing an interpretation that put us back to the old BPD issues that the new BPR have sought to clarify and overcome. The given interpretation of “primary function” in the guidance is equal to “a claim”. In other words, from the moment a “claim” is made it confers automatically a “prime function” to the article. If the evaluation of the article is only depending from the claim made then it is not the original function of the article deciding. This is simply not justified as such and cannot really be the intention. If this is the case, it would lead to enormous testing and other compliance costs which cannot be borne by companies particular in a sector of activities like textiles dominated by SME’s. These costs are excessive also if one considers that they will apply to a low volume per specific treated article. Moreover, combinations textile/biocides are variable due to the variety of textile substrates and the variable lead demand of the market. It takes already a lot of time and testing to find a good combination of textile/biocidal function which gives good results in the market. Adding an authorisation requirement in this context would make it unbearable for the companies, who would as a result have to stop making any claims. From here on, one may assume that the impact on innovation will not be negligible.
  1. Euratex would agree on the need for objective criteria to determine a “primary function” of an article. The question is how to come to that? In general we can state that the primary function of a textile article is to generate a physical or mechanical barrier between the user and his environment i.e. textile for garments prime function is to protect the body from the elements and provide comfort; mattress ticks prime function is to protect the mattress and lying comfort; upholstery fabrics prime function is to protect the seats, to provide comfort and decoration. Adding functionality is always in supplement of the basic characteristics of the textile substrate and as such it is a secondary function. To this end, you can add a colour so it look nicer, a resin finish to have a wrinkle resistance after washing, flame retardant finish to enhance fire protection and so on. The same applies to textile substrate treated with a biocidal product. Moreover, from the above one can add a second criterion to determine the “prime function” of an article which is “does the article have a market without the biocidal function?”While we believe that textiles without colours may not have a market with few exceptions, we also dobelieve that textiles without biocides can still have a market i.e. socks, bed mattresses, mosquito nets, sleeping bags; and as such the add-on biocidal function cannot be considered as the prime function of the article. On the other hand, one may ask if disinfecting toilet wipes do still have a market without the biocidal function. The liquid formulation in these wipes is a mixture whose applicator/delivery system is in the form of an article, in this case a textile carrier or a container such as determined under REACH. The textile container/carrier will not have a market if dissociated from the mixture as its primary function is disinfecting toilets and will be absolute. In this case the disinfecting toilet wipe is a biocidal product.
  2. Guidance must be consistent with the definitions provided in the BPR. New wording in the guidance may confer new interpretation that may not necessary provide the necessary clarification.
  1. A new interpretation of the legal text that may confer a status of new definition must have a clear justified legal basis and be subject to rigorous discussion with stakeholders.
  1. The guidance must stick to the terminology of the legal text as otherwise may be confusing and misleading to the companies and authorities alike.
  1. The introduction of the new notion on “public health claim” is not justified and completely unsubstantiated. The Court Judgement referred to is inadequate and bear no relevance to the notion of “public health claim” in the context of the new BPR and therefore cannot serve as a legal basis.
  1. The interpretation of the definition of “treated article” as covering both the treated article and its components is too simplistic and does not take into consideration the reality of the supply chain such as that of the textile industry. The latter has a long and fragmented supply chain in which information may have a difficult flow precisely when there are no legal requirements for such flow all the way down the supply chain. The guidance should not only advise companies with regard to the information flow but provide for such mechanism particularly with regards to article 58.
  1. Following from the above point 7, if an active substance is only used to treat a raw material but the final article placed on the market does not contain such substance, it will be prejudicial and unjustified to consider automatically that article as a treated article.

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