GiDoS NEW Responsible Person Services for BIOCIDE -- MEDICA - World Forum for Medicine



GiDoS NEW Responsible Person Services for BIOCIDE

The Biocidal Products Directive 98/8/EC (BPD): came into force the 16th of February 1998 and EU Member States had to realign before the 14th of May 2000. The main goal of the BPD is to harmonize the European market for biocidal products and to determine a high level of protection for humans, animals and the environment. The BPD also establishes a positive list of active substances which may be used in biocidal products.

What is a BIOCIDE? “Active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means.”(BPD Article 2.1(a)) Annex V of the BPD defines 23 product types, divided into 4 main groups:

1. Disinfectants and general biocidal products (ex. PT1 human hygiene biocidal products and PT2 private area and public health area disinfectants)

2. Preservatives (ex. PT8 Wood preservatives)

3. Pest control (ex. PT18 insecticides)

4. Other biocidal products (ex. PT21 antifouling products)

The Review program

A Review program, intended to last for 10 years but that has been extended until 14th of May 2014, is defined by regulation 1451/2007. The aim of the Review program is to evaluate existing active substances and decide if they can be included in the positive list of the directive or not.
During the Review, national legislation applies to BIOCIDE products including substances that will be reviewed. In the majority of the Member States this means a simplified route to market for the manufacturer.


In order to comply with the BPD, non-EU manufacturers are required to appoint a Responsible Person with a permanent office within the European Community. As a Responsible Person, GiDoS offers the following BIOCIDE services:

• Classification & Identification of Proper Regulation

• Responsible Person & Vigilance Contact Point

• Pre-market Notification:

- Notification of BIOCIDES PT1 & PT2 (98/8/EC - Art. 16) until 2014

- Authorization of new substances (98/8/EC - Art. 8)

• Safety Data Sheet keeping and updating

• Labeling and Language requirements

• Permitted Claims and Regulatory Advice

• Guidance on national requirements during review period

To receive more information about GiDoS BIOCIDE Services or our offer, please contact: