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Päivi Jokiniemi and Paul Trouth
Article related to: REACH
REACH 2018: Assess your substance to demonstrate safe use
The next step in preparing a successful registration dossier - step four - is about assessing the hazards and risks of your chemicals. For this, you need to collect all available information, compare that with the legal requirements, identify any potential data gaps and come up with ways of filling them. Your ultimate aim is to demonstrate the safe use of your substance, while making sure that testing it on animals is kept as a last resort.
The starting point for your information gathering is to analyse the current situation: what information have you got and what do you still need? These four steps will help you in your planning:
1 Gather and share existing information
Collect all the physicochemical, toxicological and ecotoxicological information that is relevant for your substance. There are five main types of information you need:
- The substance identity information;
- Physical and chemical characteristics of the substance;
- Environmental properties of the substance;
- Human health properties of the substance;
- Uses and conditions of use of the substance from manufacture to waste.
You may get the information from a variety of sources: you may have it in your own company, get it from databases or other sources in literature or on the internet.
Remember to check the identity of the test material and to respect the copyright of the data owners. You may need to pay the data owner for using their data.
You need to collect information on the current and potential future uses of your substance. You may get this from your downstream users, but also sector organisations are often able to give descriptions of the typical uses of substances used by their members.
When you gather your data, keep in mind that you also need to assess its relevance, reliability and completeness. Providing information of good quality and fulfilling the legal requirements make your life easier after registration: ECHA is less likely to request further information. Furthermore, as most of the information from your registration dossier will be made public on ECHA's website, it will be a reputational asset for your business rather than a potential embarrasment.
Remember that you are not alone: You must share your data with other companies registering the same substance. In this way, you will have access to more information to fulfil your obligations and you and your co-registrants can avoid repeating tests.
2 Consider your information needs
You also need to know the requirements which are relevant for your registration. These depend on the volume of your manufacture or import. The bigger the volume, the more information is needed.
If you are registering at the lowest tonnage band (1 to 10 tonnes a year), you will need to provide data on up to 22 properties. However, some properties will not be applicable to your substance. If you register for the next tonnage band (10 to 100 tonnes a year), you will need additional information on up to 13 properties.
Low volume, low risk substances
If you manufacture or import a substance between 1 to 10 tonnes a year, you may be able to register it with physicochemical information only. However, you can only make use of this option if there is no indication that your substance is hazardous or has diffuse or wide dispersive uses.
3 Identify information gaps
By comparing the outcome of steps 1 and 2, you will be able to identify what new information you need for your registration. This new information must be generated together with the other registrants of the same substance.
4 Generate new information or propose a testing strategy
When you have identified a data gap, you need to find a way to fill it. Remember that testing on vertebrate animals is always the last resort. Ask yourself the following questions before conducting a new test.
Is testing technically possible?
Testing for specific pieces of information can be avoided if it is technically not possible to conduct the study due to the properties of the substance. For example, if your substance is very volatile or highly reactive.
Is it possible to use alternatives to animal testing to fill in the data gap?
Examine whether you could use existing information from a structurally-similar substance (read-across), from a computer model (QSAR), from an in vitro test, or from multiple sources to build a conclusion on the property by predicting its effect (weight of evidence approach).
Recent legal changes to the REACH annexes mean that you can only provide information on skin corrosion, serious eye damage and skin sensitisation through in vitro studies.
Remember that if you decide not to test or if you use an alternative approach, you will have to justify yourself in your registration and provide relevant documentation to support your approach.
If you conclude that a new test is needed, it must be performed according to one of the methods included in the European Commission's Test Methods Regulation (or to an international test method recognised by the Commission or ECHA). Toxicological and ecotoxicological tests must be carried out in compliance with Good Laboratory Practice.
Generating new information is a joint task of companies registering the same substance. You will need to collectively decide and agree on what the next steps are: which tests to carry out and how, and how to share the costs. You will also need to agree on the classification and labelling of your substance based on the hazard data. In some cases, different classifications are possible for the same substance because of different impurities influencing the classification.
All your hazard data and classifications should be recorded in the registration dossier. In addition, if you manufacture or import more than 10 tonnes a year, you need to carry out a chemical safety assessment (CSA) and record it in a chemical safety report (CSR). You and your co-registrants can agree that the lead registrant submits the CSR jointly on behalf of everybody or you can submit your own CSR separately.
ECHA's Chemical Safety Assessment and Reporting Tool, Chesar, helps you to carry out the exposure and risk-related parts of the chemical safety assessment. It also allows the exposure scenarios to be exported for communication in the supply chain.
Use maps help in your safety assessment
For your safety assessment, you need realistic information, reflecting real-life conditions of use. Use map templates will help you to collect this information in a harmonised and structured way.
At present, templates for developing use maps and the exposure assessment inputs for workers and consumers are ready to use. Templates for the environment are also being finalised.
Your downstream user sector organisations are expected to work with these templates to generate or update the use maps for their most common uses and to make them available for you to supplement your chemical safety report.
ECHA's top five tips for data gathering
Upcoming in July
New online content on information requirements and how to avoid testing on animals as well as a practical guide for managers of small and medium-sized enterprises (SMEs) will be published on 19 July.
In addition, the current practical guides on information requirements and animal testing will be combined in one guide called ‘How to use alternatives to animal testing to fulfil your information requirements'.
The webinar on assessing hazard and risk will be on 20 July 2016.
- REACH 2018: Assess hazard and risk
- Guidance on information requirements and chemical safety assessment
- Support for low volume, low risk chemicals
- Testing methods and alternatives
- Terminology - in 23 languages
Text by Hanna-Kaisa Torkkeli
Top image: ECHA
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26 February-1 March
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Committee for Socio-Economic
18-22 March (tentative)
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13-17 May (tentative)