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FEICA position on the proposal for an EU Regulation concerning theplacing on the market and use of Biocidal Products

Published on 2009-10-21. Author : SpecialChem

FEICA, the Association of European Adhesive & Sealant Manufacturers is a multinational association representing the European Adhesive and Sealant Industry. With the support of 14 national associations and 16 direct and affiliated members, FEICA coordinates, represents and advocates the common interests of our industry throughout Europe. In this regard FEICA aims at establishing a constructive dialogue with legislators in order to act as a reliable partner to resolve issues affecting the European Adhesive and Sealant Industry.

FEICA welcomes the revision of the Biocidal Products Directive (98/8/EC); in particular the move from a Directive to a Regulation is an important step towards a harmonised EU market and level playing field for Biocidal Products. We agree that the scope should be extended to encompass treated materials and articles that are imported from outside the EU, and that contain Biocidal products that are banned in Europe. However, it is essential that a range of Biocidal products are available for product protection purposes across the diverse environmental conditions experienced around Europe and the rest of the world.

FEICA would, however, like to share several concerns regarding the proposed text as follows:

We are concerned about the interactions and contradictions with other regulations such as REACH and CLP Regulations, and this requirement, as written, will complicate and confuse the end user, as products that are not hazardous under CLP Regulations, will be required to carry the full warnings for (several) concentrated biocidal products.

Too much information is required, much of which is of doubtful use to the consumer (e.g. H & P statements of the applied active substances will not be appropriate at the level of the active in the supplied article), and without minimum threshold provisions, will require multiple labelling of multiple biocidal products in mixtures. Furthermore, it is not certain that the labelling requirements will facilitate enforcement. It may only focus enforcement on products liable to be compliant and away from those that are unlabelled yet in breach.

Art. 47 - Placing on the market of treated articles or materials -

Adhesives & sealants are often containing biocides but typically for their protection against microbial attack. They are subject to the EU classification & labelling legislation for chemical products i.e. COMMISSION REGULATION (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures. All hazardous substances leading to classification as dangerous preparations must be reported on the label according to concentrations laid down in Annex VI of this EU Regulation.

In Article 47 of the draft regulation on biocidal products, no cut-off concentration is given for the reporting of biocides on the label of treated materials or articles. This would mean that even trace quantities of biocidal substances would have to be taken into account and would have to be reported on the label. This could for example be the case for residual biocidal substances from the production batch preceding the one in question. Trace quantities of biocidal substances may be detectable despite thorough purging of production lines and vessels.

We therefore suggest to introduce cut-off values into Article 47 and aligning it with other legislation applicable to chemical substances and products such as REGULATION (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures and subsequent amendments. More particularly, we suggest the use of the cut off values given in Annex I, 1.1.2. Specific concentration limits, M-factors and generic cut-off values of COMMISSION REGULATION (EC) No 790/2009 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008.

A second point of concern is that some adhesive articles are quite small with very limited label space. We therefore suggest to allow the use of INCI names (International Nomenclature for Cosmetic Ingredients) when reporting the biocidal substance on the label. This would have the advantage that only one language is required as INCI names are not language specific. INCI names are already used on cosmetic products and may be better known and understood by consumers. Alternatively, one could also consider establishing a numbering system such as it exists for food additives (E-numbers).

Finally, if to avoid the burden of the new regulation manufacturers remove the biocidal products from their products, the net result will be an increase in spoilage and hence wastage. For example, if a supplier of adhesive to the food carton industry were to remove or reduce the amount of biocide needed to protect the sterility of the final dried film in contact with food; then the amount and type of bacteria/fungal contamination that will migrate into the foodstuff will be a significant problem, increasing the burden on recycling depots and landfill through disposal of items that have been spoilt through microbial attack, which potentially raises other more serious H&S concerns.

Source: Feica

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