REACH registration requires information on intrinsic properties of a substance. Companies manufacturing and importing chemicals in the EU/EEA are responsible for the safe use of their products. As registrants, they need to assess if their chemicals may cause adverse effects to human health and the environment. This is done based on reliable test results or by alternative information which is scientifically justified.
The REACH Regulation requires registrants to prepare a registration dossier. This is composed of a technical dossier and, where relevant, a chemical safety report, which summarises the results of a chemical safety assessment. A chemical safety report is only required if the registrant manufactures or imports a substance in quantities of 10 tonnes or more a year.
Before compiling their joint registration dossier, registrantsfirst need to evaluate all available data on the intrinsic properties of a substance. Only when this data is not adequate to meet the requirements of REACH, may additional testing be needed. However, before testing on vertebrate animals, use of alternative methods and all other options must be considered (Article 13 of REACH).
The standard information requirements are those which are required as a minimum to meet the registration obligations of REACH. They depend on the quantity of the substance that is manufactured or imported into the EU/EEA and are described in Annexes VI to X to REACH. These minimum data requirements may be adapted as appropriate. This means that certain tests may be waived.
Registrants of the same substance have to share information which is required for the registration. To avoid unnecessary animal testing and duplication of tests, study results from tests involving vertebrate animals must be shared between registrants.
Gathering all existing information
Registrants are required to collect all physicochemical, toxicological and ecotoxicological information that is relevant and available to them on the substance they are registering (regardless of whether information on a given endpoint is required or not at the specific tonnage level). To be able to use the information for registration, companies should have permission for it.
In addition, the registrant should collect information on the use, exposure and risk management measures of the substance they are registering.
Further information is provided in the Guidance on Information Requirements, R.2, section R.2.2, and R.3.
Identifying the standard information requirements
Each registrant needs to identify their information requirements according to the tonnage level in which they manufacture or import the substance, based on REACH Annexes VII to X.
The standard requirements can vary depending on whether the following apply to the substance:
(i) specific cases for registering substances from 1 to 10 tonnes per year: if you can show that your substance has a predicted low risk, you can benefit from reduced information requirements.
(ii) specific criteria as provided in column 2 of Annexes VII to X
(iii) general criteria for adaptation of information requirements given in Annex XI.
Registrants must use existing information and non-test methods to meet their information requirements. Testing on vertebrate animals should only be used as a last resort. Studies for information requirements on ecotoxicity, toxicity and physical-chemical properties should be generated using test guidelines approved by the OECD and EU.
Below you can find a simplified list of the standard information requirements. The full list of information requirementsis provided in the Guidance on Registration (section 4.1).
Note: these lists may be subject to changes as REACH annexes are updated or new methodologies become available.
Information requirements: 1-10 tonnes a year
For the lowest tonnage band, the information required is specified in Column 1 of REACH Annex VII, comprising certain physico-chemical data, toxicological information and ecotoxicological information.
| Information required forstandard registration of 1-10 tonnes a year (Annex VII of REACH) | |
|---|---|
| Non-vertebrate animal endpoints | Vertebrate animal endpoints |
| Description of the state of the substance at 20°C / 101.3 kPa | Acute toxicity: oral |
| Melting/freezing point | |
| Boiling point (if applicable) | |
| Relative density | |
| Vapour pressure (if applicable) | |
| Surface tension (if applicable) | |
| Water solubility | |
| Partition coefficient | |
| Flash-point | |
| Flammability | |
| Explosive properties | |
| Self-ignition temperature | |
| Oxidising properties | |
| Granulometry (if applicable) | |
| In vitro skin irritation/corrosion | |
| In vitro eye irritation | |
| Skin sensitisation | |
| In vitro gene mutation in bacteria | |
| Short-term toxicity on invertebrates | |
| Growth inhibition study aquatic plants | |
| Ready biodegradability (if applicable) | |
Information requirements: 10-100 tonnes a year
| Information required for standard registration of 10-100 tonnes a year (Annex VIII of REACH) Note: this is to be provided in addition to the information which is listed in Annex VII. | |
|---|---|
| Non-vertebrate animal endpoints | Vertebrate animal endpoints |
| In vitro mutagenicity study in mammalian cells or In vitro micronucleus study | In vivo skin irritation* |
| In vitro gene mutation in mammalian cells | In vivo eye irritation* |
| Activated sludge respiration inhibition test | Testing proposal for in vivo genotoxicity (if one of the in vitro tests is positive) |
| Degradation | Acute toxicity: inhalation |
| Hydrolysis | Short-term repeated dose toxicity (28-day) |
| Adsorption/desorption screening | Screening for reproductive/developmental toxicity |
Short-term toxicity on fish | |
* You are allowed to do an in vivo study only if you are not able to classify your substance based on the in vitro results.
Information requirements: 100 to 1000 tonnes a year
| Information required for standard registration of 100-1000 tonnes a year (Annex IX of REACH) Note: this is to be provided in addition to the information which is listed in Annexes VII and VIII. | |
|---|---|
| Non-vertebrate animal endpoints | Vertebrate animal endpoints |
| Stability in organic solvents | Sub-chronic toxicity (90 days) |
| Dissociation constant | Pre-natal developmental toxicity in one species |
| Viscosity | Extended One-Generation Reproductive Toxicity (if triggered) |
| Long-term aquatic toxicity on invertebrates | Long-term aquatic toxicity on fish |
| Degradation | Bioaccumulation in aquatic species |
Information requirements: 1000 tonnes or more a year
| Information required for standard registration of 1000 tonnes or more a year (Annex X of REACH) Note: this is to be provided in addition to the information which is listed in Annexes VII, VIII and IX. | |
|---|---|
| Non-vertebrate animal endpoints | Vertebrate animal endpoints |
| Further degradation testing | Long-term repeated dose toxicity (≥ 12 months) if triggered |
| Long-term toxicity to sediment organisms | Developmental toxicity in a second species |
| Extended One-Generation Reproductive Toxicity | |
| Carcinogenicity if triggered | |
Chemical safety report
A chemical safety report (CSR) is required for all substances subject to registration in quantities of 10 tonnes a year or more per registrant. The CSR documents the chemical safety assessment performed as part of the REACH registration process.
The chemical safety assessment results in the following outputs:
- Assessment of any hazards
- Identification of the conditions under which the risks from the manufacture and uses are under control, i.e. exposure scenarios
- Documentation of relevant data, justifications and conclusions in a chemical safety report
- Communication down the supply chain
Information requirements for intermediates
The information requirements for intermediates are generally reduced and there is no requirement to carry out a chemical safety assessment.
To fulfil the definition of an intermediate, the registered substance needs to be transformed into another substance and manufactured and used under strictly controlled conditions at chemical manufacturing sites. The status of a substance as an intermediate is not specific to its chemical nature but to how it is used after manufacture.
Consequently, the following two conditions must be met:
- The use of the substance meets the definition of an intermediate as described in REACH Article 3(15) and further explained in the Guidance on intermediates; and
- The substance is manufactured and/or used under strictly controlled conditions.
Further information on intermediates and the information requirements for intermediates is available in the Practical Guide: How to assess whether a substance is used as an intermediate under strictly controlled conditions and how to report the information for the intermediate registration in IUCLID.
