- The sun's out, but there's work to do!
- Finding potential substances of concern – how it happens
- Classify and label your mixtures in time
- Make sure you are included in the list of biocidal active substances and suppliers
- Pre-submission strongly advised for biocides Union authorisation
- Biocidal Products Committee adopts opinions on active substances
- Exporters under PIC must act now
- Make sense of safety data sheets and exposure scenarios – a new eGuide
- Safer products mean loyal customers
- Life in the Board of Appeal – a personal view
- New partners service for authorisation applicants
- Building consumer awareness on safety
- A challenging supporter who expects REACH to deliver a safer future
- A global response to a global challenge
- Animal welfare organisations – ECHA's critical friends
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Article related to: Biocides
Make sure you are included in the list of biocidal active substances and suppliers
Do you know what you need to do to be included in the list of active substances and suppliers, sometimes known as the Article 95 list? The amended regulation, published in April 2014, brought some changes to ensure that equal treatment of all suppliers of active substances, is fully guaranteed. Find out what the main changes are and remind yourself of the other key aspects you need to take into consideration. If you need to apply to ECHA to be included in the list, make sure you apply well before the deadline of 1 September 2015, to keep your biocidal products on the market.
Do you need to apply?
Some companies will be put on the list automatically and so do not have to make an application. These companies have been in some way 'active' in submitting applications in the past. They include companies who:
- are participants in the review programme;
- have made an application to have a new active substance approved;
- are submitters of third party dossiers.
New roles introduced by the amendment
The amendment introduces roles in the regulation. They are called 'substance supplier' and 'product supplier'.
The 'substance supplier' manufactures or imports active substances. The 'product supplier' manufactures or makes available on the EU market biocidal products. Introducing the new 'product supplier' role enables companies to access the market with their products where the 'substance supplier' is not included in the list. ECHA is working with industry to prepare some concrete examples to help.
Applicants must now indicate if they are a 'substance supplier' and/or a 'product supplier'. They also need to include the product type for which the submission is made.
The final list of active substances and suppliers will also include the date of inclusion on the list for each substance and each supplier.
To be included in the list, an application needs to be sent to ECHA through R4BP 3 and the appropriate fee must be paid within 30 days. The fees can be found in the Implementing Regulation on the fees and charges available on ECHA's website.
Discussions are ongoing to open the possibility for non-EU companies to be indicated next to their EU representatives in the list of active substances and suppliers. Follow ECHA's news to keep up with the latest developments.
The amendment enlarges the scope of data sharing under Article 95.
As before, it is obligatory to share:
- Data from tests done on vertebrate animals; and
- Data from all toxicological and eco-toxicological studies including non-vertebrates for substances on the review programme.
Now the following information must also be shared:
- Environmental fate and behaviour studies from existing active substances in the review programme.
Inquire for already submitted information
Applicants who believe they need to perform new tests or studies, must ask ECHA if the test or study has already been carried out. The inquiry has to be submitted to ECHA using R4BP 3.
Once ECHA has provided the contact information of the previous data submitter, the prospective applicant should negotiate to have access to the data. The law requires the parties to negotiate and to make every possible effort to reach an agreement on sharing the data. ECHA does not take part in these data sharing negotiations.
Data sharing disputes
If an agreement to share data cannot be reached, the parties can, as a last resort, bring a dispute case to ECHA. The dispute can be launched one month after ECHA has communicated the data owner's contact details to the prospective applicant.
ECHA will assess the dispute claim. Therefore, both parties should provide all the evidence of their efforts to reach an agreement, such as emails and letters, to ECHA.
If the parties are not satisfied with ECHA's decision, they can submit an appeal to the Board of Appeal within three months.
- Legislation and its amendments
- Draft list of active substances and suppliers
- Guidance on active substance suppliers
This guidance is currently being updated. Note also the latest draft.
- Support for applicants
- Webinar presentations
- Data sharing
Did you know?
Text by Julia Sierra
Top image: ECHA
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Biocidal Products Committee:
26 February-1 March
Committee for Risk Assessment:
6-8 March and
Committee for Socio-Economic
Management Board meeting:
23-27 March (tentative)
Member State Committee:
20-24 April (tentative)