Regulations on Biocides Products
The Biocidal Products Regulations (BPR) EU No. 528/2012 came into force on 1st September 2013. It replaces the French Directive No. 98/8 EC.
Biocide regulation also introduces new provisions that were not taken into account: data sharing, Union authorization, mutual recognition in sequence / simultaneous treated articles, substitution and exclusion criteria, the new classification Product Types (PT).
Objectives of the regulation:
- Strengthening protection of human and environment
- Speeding up assessment procedure of Active Substances (AS)
- Simplifying Marketing Authorisation (MA) of biocidal products
What is an approved supplier?
From September 1st, 2015, a biocidal product can be marketed in the European Union (EU), if the manufacturer or importer of an active substance (AS) in a biocidal product (BP) or importer of a biocidal product is included in the official list of approved suppliers.
Article 95 defines the obligations of the BPR.
The European Union by this regulatory requirement aims to encourage data sharing in order to limit animal testing, but also eliminate "free riders" that market BP by taking advantage of the transitional period, without having participated in the evaluation costs of the SA dossier.
Note : For suppliers established outside the EU area, it is possible to use the services of a European representative to be included in the list of approved suppliers.
You are concerned if:
- You are supplier and formulator of biocidal products.
You are not concerned if:
There are two cases where your company is exempted by the regulations:
- You are an active substances supplier or importer listed in the annex I of BPR, in categories 1 to 5 and 7 (PT), or biocidal products containing just those substances. The substances in the Annex I are considered non hazardous, such as lavender oil or citronella.
- You are an AS importer or supplier in biocidal products concerned by the BPR but which were not under the BPD.
Please check that the marketing of your biocidal products comply with regulatory requirements!
Procedures for inclusion in the list of approved suppliers
You must make a request through R4PB portal by filing:
- A complete file in accordance with the annex II of the RPB
- A reference to a dossier already submitted and for which the period of data protection has been exceeded (10 years for an existing AS or 15 years for a new AS)
- A letter of Access (LoA) for a completed AS file already submitted
Note : These criteria are alternative :you must choose one of three options
After your application, you will appear in the provisional list provided by ECHA during the instructional time of your file.
To determine if you have to apply, remember to ask your upstream supply chain to identify if a provider is not already approved and therefore covers you (you’ll need to obtain a license to confirm your compliance).
You can use our synthesis to better understand:
To the question "are you included in the official list of approved vendors, then a member of your supply chain answers"
However Inclusion is automatic if:
- You have participated in the review program of existing SA
- You filed an application file for a new SA
Find here the list of automatic inclusions.
Meet our Biocides services
EcoMundo is a specialist in the field of biocides. The team of experts can help you to achieve compliance with confidence. To request an inclusion in the list of approved suppliers, do not hesitate to contact us by phone: +33 01 83 64 20 54.
EcoMundo helps/supports you: Please visit our webinar son the topic of Article 95 and find our articles on the blog!
Need advice? Contact Us: contact@ecomundo.eu
