EU Registration and Risk Assessment
REACH, Biocidal Products Regulation (BPR)
For Successful REACH registrations
We assist you in successfully obtaining REACH registration for your chemicals. Experienced toxicologists evaluate the available data and apply QSAR and read-across to fill possible data gaps. We use state-of-the-art models for exposure and emission assessment to demonstrate sufficient risk control. Our dossiers are ready for filing and we can even submit them on your behalf if necessary. Our support does not end with the registration phase, however. If your substances are subject to dossier evaluation, we provide assistance with responses to authorities’ requests, dossier updates and subsequent communication. With our extensive knowledge in exposure models assessment we can update an existing risk assessment, which is key in informing authorities that the risks have been adequately checked. For your Risk Management Option studies and Authorization dossiers we combine knowledge from all of the necessary disciplines to develop an approach that specifically fits your needs and the substance requirements.
We handle the process and the paperwork for Biocidal Products Regulation
For Biocidal substances falling within the scope of the BPR, we support you in obtaining active substance approval and product authorization, covering all of the required steps. Our services include the set-up of registration strategies, dossier preparation and submission, and post-submission services including discussions with the authorities. We can assist you by coordinating efficacy and safety studies, risk assessment and dossier preparation. Personal contact and communication are naturally a vital part of this.
A successful registration starts with a proper substance identification, which ECHA considers to be a key element of the dossier. We will evaluate the analytical data of your substance and, based on the composition and impurities , determine the SIP (Substance Identification Profile) that best fits your substance. We will also check the registration status, possible identified uses and can even do an enquiry with ECHA on your behalf.
2. SIEF communication
Data have to be shared amongst all registrants of the same substance. We will support you in the SIEF communication, advise on strategic issues and perform initial data evaluation including valuation of the studies.
3. Data evaluation
The available data will be evaluated and summarized in IUCLID. We will draw robust conclusions on the EU classification and labelling, PBT status and derive DNELs and PNECs. For endpoints where no data is available, we will assess the possibilities for waiving statements and read across to other substances by use of an integrated approach, trying to avoid testing where possible. Based on our experience we know which arguments work and don’t work, enabling us to prepare an advice that perfectly fits your position.
4. Identified uses and Exposure Scenarios
A complete overview of the identified uses of your substance will be created based on information from your company (e.g. sales department), your customers and open sources. The identified uses will be condensed to comprehensive Exposure Scenarios and presented in a use tree, which is the basis for the compilation of Exposure Scenarios.
5. Exposure assessment
For each of the exposure scenarios, exposure of workers and consumers as well as emission to the environment will be assessed by use of the latest versions of the applicable tools like Chesar, EASY TRA, EUSES, Advanced REACH tool. With our long history in the field of exposure assessment, we build scenarios with a proper justification of safe use and exposure conditions and controls that fit the real conditions from your and your customers companies as much as possible.
6. Chemical Safety Report
As a final step in the risk assessment, the Chemical Safety Report will be prepared, in which all assumptions, calculations and evaluations are described in a comprehensive way.
7. Testing plans
In case data is not available for a certain endpoint, the dossier will be completed by waiving statements, by justifying why a certain study is not necessary, and testing proposals in case a test is needed to draw conclusions. We can provide you with quotations for all possible studies and monitor them on your behalf.
8. (Extended) Safety Data Sheets
We will extract the necessary information for your Safety Data Sheet, since information on the safe use of chemicals will need to be summarized in your SDS, which is extended with Exposure Scenarios in case a substance is classified as hazardous and produced in amounts exceeding 10 tons per year.
9. Dossier completion
We will prepare your technical dossier in IUCLID and make sure that is passes the obligatory completeness check. If you like so, we can also create the company dossier and do the submission on your behalf.
10. Follow up
Once your dossier is submitted and the substance is registered, it may become subject to several evaluation processes or new data may become available. We will take care of the accompanying communication and update the dossier on the requested topics.
Is any of the substances you produce or use listed on the candidate or authorisation list? Do you need support in the preparation of the relevant documents and dossier parts? As the authorization process has just started, there is no ‘standard’ way forward and each substance requires a specific approach. Your situation is unique; together we will work on a project set-up that fits your needs. Our carefully selected authorization team provides the optimum combination of in-depth knowledge, applied content and communication experience together with efficient service. Our network and track record in representing our industry clients in dealing with relevant regulatory stakeholders for REACH authorization (ECHA, the European Commission, EU Member States and national safety and environmental bodies) demonstrates our particular strengths in these fields.
Biocides Product Authorization and Active Substance Support
As soon as the (existing) active substances used in your biocidal products are positively evaluated in the context of the Biocidal Product Regulation, (BPR, EU 528/2012), they can be or continue to be marketed for the specified product category. However, a product dossier needs to be submitted in order to get approval for your specific product type in one or more European countries, or union authorization in case your product is applied for? all EU markets. Although the active substance dossier contains most of the necessary information, the development of the product dossier can still be a major challenge, especially in cases where several active substances are used.
With our experience in the development and evaluation of active substance as well as product dossiers, we are ready to assist you with the following activities:
- Data requirement analysis
- Completeness check of any existing biocide dossiers
- Quality assessment of existing data
- Mediate in obtaining a letter of access (if you are not the data holder)
- Prepare a cost-effective test strategy with a minimum of required studies, and clear and scientific based waivers
- The complete risk assessment of your substance and/or products
- Dossier compilation and submission
- Dealing with the CA (Competent Authority) and subsequent comments after submission
With our support you will ensure working in line with the conditions of the regulation.