SGS Informs about New Biocidal Product Regulation for the European Market

July 25, 2012 - PRLog -- A biocidal product is a substance or a mixture with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on any harmful organism by any means other than mere physical or mechanical action.

Through this regulation, biocidal products and their active substances are separated in 4 groups and in 22 product-types (PT).

Group 1: Disinfectants

Product-type:
PT 1: Human hygiene
PT 2: Disinfectants and algaecides not intended for direct application to humans or animals
PT 3: Veterinary hygiene
PT 4: Food and feed area
PT 5: Drinking water

Product examples:
PT 1: Soap with antibacterial claim
PT 2: Disinfectant for swimming pool Detergent with antibacterial claim

Group 2: Preservatives

Product-type:
PT 6: Preservatives for products during storage
PT 7: Film preservatives
PT 8: Wood preservatives
PT 9: Fiber, leather, rubber and polymerised materials preservatives
PT 10: Construction material preservatives
PT 11: Preservatives for liquid-cooling and processing systems
PT 12: Slimicides
PT 13: Working or cutting fluid preservatives

Product examples:
PT 6: Preservative in paint, ink, detergent, etc.
PT 8: Wood varnish with insecticide properties

Group 3: Pest control

Product-type:
PT 14: Rodenticides
PT 15: Avicides
PT 16: Molluscicides, vermicides and products to control other invertebrates
PT 17: Piscicides
PT 18: Insecticides, acaricides and products to control other arthropods
PT 19: Repellents and attractants
PT 20: Control of other vertebrates

Product examples:
PT 14: Rat poison paste
PT 19: Mosquito repellent wristband

Group 4: Other biocidal products

Product-type:
PT 21: Antifouling products
PT 22: Embalming and taxidermist fluids

Requirements for Technical Dossiers

Biocidal products and their active substances have to be authorized before use or placing on the EU market. All treated product shall contain only authorized biocidal active substances.
To be authorized, the EU manufacturer or importer may submit a technical dossier in IUCLID format to ECHA (http://echa.europa.eu/). Highlights of the requirements for technical dossiers are summarized in Table 2.

Active substance:

•   ID of manufacturer or importer
•   ID of substance (including manufacture)
•   Physico-chemical properties of the active substance
•   Methods of detection and identification
•   Effectiveness against target organisms
•   Intended uses and exposure
•   Toxicological properties
•   Ecotoxicological properties
•   Measures necessary to protect humans, animals and the environment
•   Classification, labelling and packaging
•   Summary and evaluation (risk assessment)

Biocidal product:

•   ID of manufacturer or importer
•   ID of biocidal product
•   Physico-chemical properties of the active substance
•   Methods of detection and identification
•   Effectiveness against target organisms
•   Intended uses and exposure
•   Toxicological properties
•   Ecotoxicological properties
•   Environmental fate and behaviour
•   Measures necessary to protect humans, animals and the environment
•   Classification, labelling and packaging
•   Summary and evaluation (risk assessment)



Labeling of Treated Articles

One of major modifications of this new legislation concerns treated articles. A treated article is a substance, a mixture or an article which has been treated with, or intentionally incorporates, one or more biocidal products. Treated articles shall be labeled, if:
•   there is a claim on biocidal properties,
•   there is a possibility of contact with humans or release into the environment,
•   it is required as a condition of an active substance authorization.

The label should contain:

•   a statement that the treated article incorporates biocidal products;
•   where substantiated, the biocidal property attributed to the treated article;
•   the name of all active substances contained in the biocidal products;
•   the name 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.

About SGS REACH Services

SGS will follow up and inform interested parties as developments on REACH and other legislation occur. SGS’ REACH expertise combined with experience in consumer product supply chains provides a central point of contact for global solutions. Please contact SGS (www.sgs.com/reach) if you would like to learn more about how SGS can support your REACH compliance activities.


Contact details:

SGS Consumer Testing Services
Jerome Vandenbroucke
REACH Technical Expert
Bât 8 - Parc du Golf
CS 30584
13 594 - Aix en Provence Cedex 3
France

t: +33 4 42 97 78 50
Email: cts.media@sgs.com
Website: http://www.sgs.com/pages/consumer-testing/sgs-consumer-go...

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