New Active Substances for Use in Biocidal Products Formalized by EU

In September 2015, the EU announced four new Commission Implementing Regulations regarding the approval of Propiconazole, Folpet and Glutaraldehyde as active substances for use in biocidal products

Uses for Biocidal Products

Biocidal products are used to control unwanted organisms that are harmful to human or animal health, or that cause damage to human activities. These harmful organisms include pests (e.g. insects, rats or mice) and microorganisms (e.g. molds or bacteria). Biocidal products include insecticides (except those used for plant protection purposes, which are regulated by Regulation (EU) No 1107/2009), insect repellents, disinfectants, and preservatives for materials such as wood, plastics and fibers, as well as anti-fouling paints for the protection of ship hulls.

Nowadays, biocidal products play an important role in EU citizens’ daily lives. For example, insecticides and disinfectants are essential for public health, as they help control vector-borne diseases (e.g. malaria, dengue fever or chikungunya), food-borne diseases (e.g. salmonellosis, listeriosis) and hospital-acquired infections (e.g. MRSA). They are also widely used in materials such as plastics, paints, textiles and wood to protect them against microbial, fungi or insect decay. Due to their intrinsic properties, biocidal products can pose risks to humans, animals and the environment. As a result the EU has implemented strict rules and procedures to ensure a high level of protection for human health, animal health and the environment. Therefore, before active substances can be used in biocidal products they need to be assessed and approved for such use at EU level.

The Biocidal Product Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market and use of biocidal products which are used to protect humans, animals, materials or articles against harmful organisms, like pests or bacteria, by the action of the active substances contained in the product.

The four new Regulations are:

- Commission Implementing Regulation (EU) 2015/1609 [1]
- Commission Implementing Regulation (EU) 2015/1757 [2]
- Commission Implementing Regulation (EU) 2015/1758 [3]
- Commission Implementing Regulation (EU) 2015/1759 [4]

Existing Active Substances for Use in Biocidal Products

The four new Commission Implementing Regulations relate to the approval of propiconazole, folpet and glutaraldehyde as active substances for use in biocidal products for product types 2, 3, 4, 6, 7, 9, 11 and 12 imported into the EU. Details of the changes are shown in table 1 (http://www.sgs.com/en/Our-Company/News-and-Media-Center/News-and-Press-Releases/2015/10/SafeGuardS-17115-EU-Approves-Propiconazole-Folpet-and-Glutaraldehyde-as-Active-Substances-for-Use.aspx) of the Safeguards bulletin.

Enforcement Action

Commission Regulation (EU) No. 2015/1609, of September 24 2015, entered into force on October 14 2015. Commission Regulations (EU) No. 2015/1757, 2015/1758, 2015/1759, of September 28 2015 shall enter into force on October 21 2015.

Effects of the New Regulation

This update has the potential to affect manufacturers, importers or downstream users in the European Union (EU) as they need to follow the approved list of active substances for use in biocidal products of EU Biocides Regulations 528/2012, as outlined in Table 1. In addition, they must ensure compliance with the four new regulations, which came into force in October 2015.

References:

[1] Commission implementing regulation (EU) 2015/1609 – 24 September 2015 (http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2015.249.01.0017.01.ENG)

[2] Commission implementing regulation (EU) 2015/1757 – 28 September 2015 (http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1444621212967&uri=CELEX:32015R1757)

[3] Commission implementing regulation (EU) 2015/1758 – 28 September 2015 (http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1444621212967&uri=CELEX:32015R1758)

[4] Commission implementing regulation (EU) 2015/1759 – 28 September 2015 (http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1444621212967&uri=CELEX:32015R1759)

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Contact details:

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Supaporn Surawattanaboon
Research and Development Chemist
SGS (Thailand) Limited
Bangkok, Thailand

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