15 October 2013

Important Information for Textile Customers

Update to previous statements for manufacturers of treated materials and articles. Regarding Labelling requirements under Article 58 of the Biocidal Products Regulation (EU) No 528/2012

Dear Customer, Since our last communication the EU has further refined it’s Draft Note for guidance on Treated Articles. The biocidal products Directive was repealed by REGULATION (EU) No 528/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL concerning the making available on the market and use of biocidal products.

The Regulation introduces new obligations for suppliers of biocides and for the first time brings certain obligations for manufacturers and suppliers of treated articles with regards to labelling. In accordance with chapter XIII Article 58 regarding the placing on the market of treated articles it is stated that labelling obligations apply where:-

in the case of a treated article containing a biocidal product, a claim is made by the manufacturer of that

treated article regarding the biocidal properties of the article, or

in relation to the active substance(s) concerned, having particular regard to the possibility of contact with

humans or the release into the environment, the conditions associated with the approval of the active

substance(s) so require.

The label referred to in the first subparagraph shall provide the following information:

(a) a statement that the treated article incorporates biocidal products;

(b) where substantiated, the biocidal property attributed to the treated article;

(c) without prejudice to Article 24 of Regulation (EC) No 1272/2008, the name of all active substances contained in the biocidal products;

(d) the name of all nanomaterials contained in the biocidal products, followed by the word ‘nano’ in brackets;

(e) 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.

Draft Note for Guidance We must draw your attention to the European Commission Draft Note for Guidance on Treated Articles wherein a clear distinction is made between a biocidal function and a biocidal property for a treated article. Any treated article that has a primary biocidal function shall be considered a biocidal product and will

therefore fall under the obligations to register as a biocidal product in accordance with the Regulation. Textiles and apparel that have been treated with an antimicrobial product to preserve freshness throughout the product’s lifecycle are not biocidal products. Where your product is apparel treated with PURE and no biocidal function but merely a biocidal property is claimed, it will be considered a treated article.

According to the Draft Note for Guidance on Treated Articles it is proposed that the following types of claims will be viewed under the Biocidal Products Regulation as a claim regarding the biocidal properties of the treated article.

Contains a preservative to control microbiological deterioration

Contains a preservative to antagonise the settlement of microorganisms on the surface of the treated article.

Contains a preservative to hamper or prevent the development of odour on/in the treated article (e.g. Treated with PURE by HeiQ)

Consequently any treated articles carrying related claims meet the first criteria for the labelling requirements set out in Article 58(3)(a)-(e) and must be labelled accordingly going forward.

Active Substances The active substances in the products identified below are currently in the review process as notified substances: To assist with the labelling requirements these actives are: Product Active

HeiQ Pure TF silver

HeiQ Pure KF silver

HeiQ Pure EH silver chloride

HeiQ Pure QSC Dimethyloctadecyl[3-(trimethoxysilyl) propyl]ammonium chloride

Label Recommendation As an example of compliant labelling for garments we recommend: (a)

Contains a biocidal product (b)

to preserve freshness. (c)

Active ingredient: (insert name of actives, e.g. silver).

(e)May be disposed of in household waste.

Label Positioning

The labelling text should be positioned on the article or packaging according to Article 58(6) i.e. The labelling shall 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 official language or languages of the Member State of introduction, unless that Member State provides otherwise.

Alternatively Pure Hang-Tags can be utilized on the articles, for Hangtag requests contact: Marlen Philipp (philipp@heiq.com)

We aim to keep all of our customers updated with relevant information as the active authorisations proceed and to actively support you in compliance going forward. In the meantime if you have further questions or concerns on labelling requirements please do not hesitate to contact us. HeiQ Materials AG Mark McKay Head of Compliance