The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) was applicable from 1 September 2013, it will be enforced on 1 September 2015.

The majority of Biocidal Products Regulation:

 Objection of management:

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 biocidal product. 

Content of management:

1.      All biocidal products require an authorisation before they can be placed on the market.

2.    The active substances contained in that biocidal product must be previously approved.

3.      The active substances must come from the suppliers already listed in European.

4.      All articles added in or processed by biocidal products such as furniture as well as the included active substances or biocidal product used are required to satisfy above conditions, otherwise the articles can’t be placed in European market.

Exceptions:

1.      Active substances under the review programme as well as biocidal products containing these active substances can be placed on the market while awaiting the final decision on the approval. 

2.      Provisional product authorisations for new active substances that are still under assessment are also allowed on the market.

Test requirement:

l   Reduction of animal testing and encouraging the use of alternative testing methods.

l   Introduce mandatory data sharing obligations.

Approved by and time limit:

The approval of active substances takes place at Union level. ( Gettime:2 years / License Validity:10 years)

The subsequent authorisation of the biocidal products at Member State level. This authorisation can be extended to other Member States by mutual recognition. However, the new regulation also provides applicants with the possibility of a new type of authorisation at Union level (Union authorisation).

Types of biocidal products:

BPR the biocidal products are classified into 22 biocidal product-types, grouped in four main areas.As a result of excluding biocidal products used as preservatives for food and feedstock from the scope, there is one less product type compared to the previous directive. 

Our Service for BPR:

1.      Applicability assessment on European biocidal Products regulation

2.      Application of new active substances

3.      Supplier qualification of active substances application

4.      Application of biocidal products

5.      Biocidal products and articles label

6.      Other consulting services

More information for inquiry, please contact with us: 86 21 6275 7818, 6275 7810

E-mail address: frankwang@randis.cn