- Improving REACH registration and authorisation
- Exploring the universe of registered substances
- Moving away from BPA in thermal paper
- Investing in good registration data is an investment in safety
- Get to know ECHA’s Submission portal for poison centre notifications
- Assessing endocrine disrupting properties for biocides
- Controlling exposure to harmful chemicals at work
- Which pieces of EU legislation apply to your substances?
- Stopping products sidestepping enforcement through rebranding
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Investing in good registration data is an investment in safety
Your dossier is your business card, and it reveals your commitment to your customers, stakeholders and the environment. Being compliant with REACH is not only an obligation but also an act of social responsibility. We have put together our top tips to help you improve your registration dossier.
Make sure your registration is compliant
Passing a completeness check does not mean that your registration dossier is compliant with the information requirements under REACH. The completeness check only ensures that your registration addresses all the required elements. The content of your dossier is evaluated in detail during the compliance check.
If your dossier is assessed to be non-compliant, ECHA will send you a decision through REACH-IT, requesting additional testing or further information. You will be given a deadline by which you need to generate that information and update your registration.
If you do not provide the required information by the given deadline, ECHA will inform relevant Member State authorities about your non-compliant registration. Enforcement authorities may consider actions against your company, for example, you may face fines.
Five top tips
You can start improving your registration by following these tips:
1. Identify your substance correctly.
Accurately identifying your substance is a prerequisite to most REACH processes. If it is not clear which substance is registered, it is impossible to assess if any of the other data in your dossier is correct. There are things you can do to improve your substance identity information.
Use appropriate identifiers such as the chemical name, EC and CAS numbers, for example, benzene (EC 200-753-7, CAS 71-43-2; 1076-43-3).
Make sure you describe the manufacturing process in enough detail. This is relevant for substances of unknown or variable composition, complex reaction products or biological materials (UVCBs). The information on the composition of your substance such as any constituents, groups of constituents or impurities with their concentration values is relevant to all substances. You must also provide analytical data that confirms the substance composition and identity.
It is also important to ensure that you are in the correct joint submission.
2. Include physicochemical, toxicological and environmental information.
REACH specifies the minimum information requirements per tonnage band. The higher the tonnage band in which your substance is manufactured or imported, the more information you need to provide. Keep in mind that at any tonnage band you need to include all available physicochemical, toxicological and ecotoxicological information that is relevant to your substance.
Physicochemical properties are key information for any chemical assessment as they indicate what the distribution, behaviour and fate of chemicals in the human body and the environment may be. Using the CLP Regulation test methods to fulfil REACH requirements will ensure that the results are also adequate for classification and labelling.
Physicochemical testing should be finalised before any other studies are initiated, because the physicochemical properties of a substance may influence the study design of those other studies. If you notice any inconsistencies in your data, make sure you explain the unexpected findings.
Toxicological and ecotoxicological information refer to the potential adverse effects that may be caused if exposed to a harmful chemical. Carefully consider possibilities for adaptation and only initiate further testing if needed. If you need new data for certain toxicological properties, for example, for skin and eye irritation or for skin sensitisation, you first have to conduct in vitro testing. This is to ensure that animal testing is only used as a last resort. For other toxicological properties, in general you will need in vivo testing.
For the tests specified in REACH Annexes IX and X, you first have to submit a testing proposal to ECHA. You can only start testing once you receive a decision accepting the proposal. For testing proposals on vertebrate animals, ensure you include the considerations for why adaptation possibilities can not be used and why animal testing is necessary.
For aquatic toxicity studies, consider performing long-term studies (on invertebrates and fish) if your substance has low water solubility, as this information is needed to assess the toxicity of your substance.
All new toxicological and ecotoxicological tests must be carried out in line with the principles of good laboratory practice. Make sure you sufficiently describe your test results so the effects of the substance can be assessed and so you can advise on the safe use of your chemical.
3. When applying a read-across approach, justify your hypothesis well.
Read-across is the most commonly used alternative to testing chemicals on animals under REACH. ECHA has published the Read-Across Assessment Framework (RAAF), to show you how experts evaluate read-across cases and ensure consistent assessments. Use the RAAF to check whether your read-across approach may be considered acceptable by ECHA and take further action if needed, for example, by performing additional testing.
4. Update your dossier regularly.
This should be done especially when you have new information on substance properties, or new knowledge on the uses of your substance. By doing so, you can avoid facing regulatory action.
5. Classify your substances correctly.
It is your responsibility to classify and label your substance properly. If there is a harmonised classification for your substance, use it and check if it has been updated. Otherwise, use the information from your dossier to self-classify and revise it whenever new data becomes available.
There is plenty of information available to improve compliance. Check this information and build a process in your company to make sure your registration dossiers are up to date and compliant.
Good data is the first step towards a sustainable supply chain where substances of concern are properly managed. By having the right information at hand from the start, authorities can focus their actions on the right substances, companies have regulatory certainty, and the public in general has access to information on chemicals.
Text by Irene Poza Latorre
Published on: 16 May 2019
Top image: © iStock.com/oatawa
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