SGS Informs about New Biocidal Product Regulation for the European Market
In June 2012, the European Commission has published the new biocidal product regulation (EU) No 528/2012 to administer the making available on the market and the use of biocidal products.
PROVENCE, FRANCE, July 27, 2012
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 (link to: 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 (link to: http://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-goods-and-retail.aspx
SGS is the world's leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With 70,000 employees, SGS operates a network of over 1,350 offices and laboratories around the world.
operates a network of over 1'250 offices and laboratories around the world.
SGS Consumer Testing Services ensures the quality and safety of every kind of consumer products, from textiles, electronics and furniture to food and automotive. Our customers in these distinct manufacturing industries rely on our inspection and testing capabilities and laboratories to help them comply with the regulatory requirements governing their products, as well as to ensure the integrity of the inputs received from their suppliers.
For more information, please visit: http://www.sgs.com/cts