- 4. Vurdering af fare og risiko
- Oplysningskrav: 1 til 10 ton pr. år
- Reducerede oplysningskrav
Reduced information requirements
If you manufacture or import your phase-in substance between 1-10 tonnes per year, you may be able to register it with a reduced set of information, covering only its physicochemical properties. However, a reduced set can only be used if:
- there is no indication that the substance has carcinogenic, mutagenic or toxic to reproduction (CMR, category 1A or 1B), persistent, bioaccumulative and toxic (PBT) or very persistent, very bioaccumulative (vPvB) properties, and
- there is no indication that a substance with dispersive or diffuse uses would be classified as hazardous for human health or as an environmental hazard under the CLP Regulation or has nanoforms (unless those nanoforms are soluble in biological and environmental media).
If there is an indication that your substance could have CMR or PBT/vPvB properties, or it is likely to be classified as hazardous under CLP or has nanoforms and has dispersive or diffuse uses (also called Annex III criteria), it must be registered with the full Annex VII information including physicochemical, toxicological and ecotoxicological information.
Ændring af bilag III
Bemærk venligst, at bilag III er blevet ændret ved forordning (EU) 2018/1881, hvad angår bestemmelserne om nanomaterialer (Kommissionens forordning (EU) 2018/1881 af 3. december 2018 om ændring af Europa-Parlamentets og Rådets forordning (EF) nr. 1907/2006 om registrering, vurdering og godkendelse af samt begrænsninger for kemikalier (REACH) for så vidt angår bilag I, III, VI, VII, VIII, IX, X, XI og XII med henblik på håndtering af stoffers nanoformer (EUT L 308 af 4.12.2018, s. 1-20).
Reduced information requirements - how to check the benefits
How to check if you benefit from reduced information requirements
The following steps will help you check whether your substance can be registered with information only on its physicochemical properties.
If your substance meets the criteria set in Annex III to REACH, it needs to be registered with the full Annex VII information.
When gathering information on your substance, you should take into account all of its main constituents, impurities and additives. If you search ECHA’s registration database, you should use the identifiers for your substance and all the main constituents, impurities and additives you can identify.
If your substance has already been registered or data is available within the joint submission, you should use the available information to the extent possible to understand if the Annex III criteria apply.
Your registration also needs to be in line with the joint submission obligation. This means that you need to discuss with other companies about substance sameness, share data and costs with them and, subsequently, submit your registration as part of a joint submission. Any relevant data you own must also be included in the registration dossier.
If the information gathered shows that your substance has potential for carcinogenic, mutagenic or reprotoxic (CMR) (category 1A or 1B) or persistent, bioaccumulative and toxic (PBT) or very persistent, very bioaccumulative (vPvB) properties, you need full Annex VII information for your REACH registration except if you have valid reasons to disregard the information gathered.
If the information shows that your substance is likely to be classified as hazardous to human health or the environment or has nanoforms and it has diffuse or dispersive uses, you also need full Annex VII information for your registration.
For instance, the following uses are considered dispersive/diffuse uses:
- consumer uses;
- uses by professional workers (i.e. uses by professionals outside industrial sites);
- article uses, unless these are only limited to industrial sites;
- uses at industrial sites (including uses of articles), if not limited to a few sites only and carried out under rigorous containment (with minimisation of environmental emissions).
When assessing the uses, take into account in-house marketing information and information provided by customers or downstream sector organisations for characterising the uses of the substance.
The REACH Guidance on information requirements and chemical safety assessment, chapter R.12 gives more information on the use descriptor system, which can be useful when determining whether your substance has dispersive or diffuse uses.
However, you may have valid reasons to disregard the information found. If this is your case, you have to gather evidence from different sources and to show that you can still benefit from the reduced information requirements.
You should also check the following information to see if your substance meets the Annex III criteria:
- REACH registrations and notifications in the C&L inventory;
- Other regulatory data available for the substance (e.g. Annex VI to CLP);
- Available experimental data (e.g. in the QSAR Toolbox);
- Alternatives to test data (e.g. QSAR, read-across, in vitro).
Based on the information gathered, one of the following cases will apply:
- You already know that your substance fulfils at least one of the Annex III criteria. In this case, you must submit the full Annex VII with data with physicochemical, toxicological and ecotoxicological information in your registration.
- You have concluded that your substance does not fulfil the Annex III criteria, but you may have found information from other sources that your substance is likely to meet the Annex III criteria.
If so, you must provide in section 14 of the IUCLID dossier a justification for disregarding this information if you want to submit your registration with reduced information requirements.
- You have concluded that your substance does not fulfil the Annex III criteria. You have also not found any other indications from any sources that your substance is likely to meet the Annex III criteria. In this case, you can choose between two options:
- You can submit your registration dossier with physicochemical information only (and other relevant information available to you), with the relevant justification included in section 14 of the IUCLID dossier.
- You can submit your registration with full Annex VII information and claim a fee waiver to have a reduction in your registration fee. No justification is needed in this case.
Reduced information requirements - related documents
Reduced information requirements - see also regulation
See also under the Legislation section
Reduced information requirements - see also