News


  • 23 April 2018 : The European Commission validates the BPC opinions and publishes the corresponding Legal acts :

    - COMMISSION IMPLEMENTING DECISION (EU) 2018/619 of 20 April 2018 not approving PHMB (1415; 4.7) as an existing active substance for use in biocidal products of product-types 1, 5 and 6

    - COMMISSION IMPLEMENTING REGULATION (EU) 2018/613 of 20 April 2018 approving PHMB (1415; 4.7) as an existing active substance for use in biocidal products of product-types 2 and 4

Additional information

EUROPEAN REGULATORY PROCESS

Image

> European Union : BPD / BPR process

03.2002 : PHMB applications initially notified by Paréva were : PT1, PT2, PT3, PT4, PT9, PT10 and PT11.

07.2007 : PHMB applications actually submitted were : PT1, PT2, PT3, PT4, PT5 and PT6.  

10.2008 : For technical reasons, PHMB applications for PT9, PT10 and PT11 were not submitted.

For financial reasons, PHMB application for PT3 was finally not supported.

 

The Product Types (PTs) definitions are given in the Annex V of the Regulation (EU) 528/2012, known as the “Biocide Products regulation” (BPR).

The definition of the PTs of interest are given bellow :

 

ANNEX V

BIOCIDAL PRODUCT-TYPES AND THEIR DESCRIPTIONS AS REFERRED TO IN ARTICLE 2(1)

 

MAIN GROUP 1: Disinfectants

These product-types exclude cleaning products that are not intended to have a biocidal effect, including washing liquids, powders and similar products.

 

Product-type 1: Human hygiene

Products in this group are biocidal products used for human hygiene purposes, applied on or in contact with human skin or scalps for the primary purpose of disinfecting the skin or scalp.

 

Product-type 2: Disinfectants and algaecides not intended for direct application to humans or animals

Products used for the disinfection of surfaces, materials, equipment and furniture which are not used for direct contact with food or feeding stuffs.

Usage areas include, inter alia, swimming pools, aquariums, bathing and other waters; air conditioning systems; and walls and floors in private, public, and industrial areas and in other areas for professional activities.

Products used for disinfection of air, water not used for human or animal consumption, chemical toilets, waste water, hospital waste and soil.

Products used as algaecides for treatment of swimming pools, aquariums and other waters and for remedial treatment of construction materials.

Products used to be incorporated in textiles, tissues, masks, paints and other articles or materials with the purpose of producing treated articles with disinfecting properties.

 

Product-type 3: Veterinary hygiene

Products used for veterinary hygiene purposes such as disinfectants, disinfecting soaps, oral or corporal hygiene products or with anti-microbial function.

Products used to disinfect the materials and surfaces associated with the housing or transportation of animals.

 

Product-type 4: Food and feed area

Products used for the disinfection of equipment, containers, consumption utensils, surfaces or pipework associated with the production, transport, storage or consumption of food or feed (including drinking water) for humans and animals.

Products used to impregnate materials which may enter into contact with food.

 

Product-type 5: Drinking water

Products used for the disinfection of drinking water for both humans and animals.

 

MAIN GROUP 2: Preservatives

Unless otherwise stated these product-types include only products to prevent microbial and algal development.

 

Product-type 6: Preservatives for products during storage

Products used for the preservation of manufactured products, other than foodstuffs, feedingstuffs, cosmetics or medicinal products or medical devices by the control of microbial deterioration to ensure their shelf life.

Products used as preservatives for the storage or use of rodenticide, insecticide or other baits.

 

PAREVA’s PHMB : NOWADAYS  STATUS

4 October 2017 : Paréva’s PHMB was discussed at the Biocidal Products Committee (BPC).

The BPC proposed to approve PHMB for PT2 and PT4 and to not approve PHMB for PT1, PT5 and PT6.

23 April 2018 : The European Commission validates the BPC opinions and publishes the corresponding Legal acts :

- COMMISSION IMPLEMENTING DECISION (EU) 2018/619 of 20 April 2018 not approving PHMB (1415; 4.7) as an existing active substance for use in biocidal products of product-types 1, 5 and 6

- COMMISSION IMPLEMENTING REGULATION (EU) 2018/613 of 20 April 2018 approving PHMB (1415; 4.7) as an existing active substance for use in biocidal products of product-types 2 and 4