Standard information requirements
Under REACH, the standard information requirements are those that are required as a minimum to meet your registration obligations, and they depend directly on how much of a substance you manufacture or import into the EU/EEA.
- Follow the requirements described in Annex VI to REACH for the general information required from all registrants, which covers also the identification of your substance.
- Follow the requirements described in Annexes VII to X to REACH for the specific hazard information relevant for the different tonnage bands. Note that the requirements add up as the volume increases.
- Keep in mind that in some cases you may need information relevant for higher tonnages to ensure the safe use of your substance.
- Perform all new tests for physico-chemical hazards according to the methods set out in the CLP Regulation. You will thereby ensure that the results can be adequate for classification and labelling under the CLP Regulation and that they are consistent with the United Nations’ Recommendations on the Transport of Dangerous Goods manual of tests and criteria.
- Remember that some of the physico-chemical properties are interlinked with other information requirements, so check that there is consistency and explain any unexpected findings
- Remember that the REACH annexes are sequential. Therefore, Annex VII requirements (e.g. for in vitro irritation testing) should be fulfilled before considering the Annex VIII ones (e.g. in vivo testing). However, in other circumstances, you may perform an Annex VIII test to fulfil also an Annex VII requirement. For example, if your substance does not exert toxic effects, you can first perform the 28-day repeated-dose toxicity (Annex VIII) study) and use the results within a weight-of-evidence approach to fulfil the acute oral toxicity endpoint (Annex VII).
- If new data for skin and eye irritation and for skin sensitisation needs to be generated, you first have to perform the in vitro tests, irrespective of the annual tonnage of the substance
- Any positive result in one of in vitro experiments must be followed up by an in vivo study. However, a testing proposal must be submitted before initiating mutagenicity testing on vertebrate animals. If you do not consider as necessary to perform an in vivo follow-up test, you must provide a scientifically-sound and well-documented justification in your dossier.
- For substances manufactured or imported at 100 tonnes/year or more (Annex IX or X of REACH) if:
1) in vivo genotoxicity test on somatic cell is positive and
2) no clear conclusion can be made on germ cell mutagenicity,
then a germ cell genotoxicity study (OECD TG 488 or OECD TG 483) may be required.
- A screening study (OECD TG 421 or OECD TG 422), required at Annex VIII, does not fulfil the information requirement for a sub-chronic toxicity study (90-days, OECD TG 408)), nor for a pre-natal developmental toxicity study (OECD TG 414) or an extended one-generation reproductive toxicity study ((EOGRTS); OECD TG 443).
- Remember, that pre-natal developmental toxicity studies (test method OECD TG 414) on two species are part of the standard information requirements for a substance registered for 1000 tonnes or more per year (Annex X). According to the test method OECD TG 414, the rat is the preferred rodent species and the rabbit the preferred non-rodent species. If you consider another species as more relevant, provide a justification.
- ECHA has published a technical report on how it identifies and concludes on the design of the extended one-generation reproductive toxicity study (EOGRTS). This report discusses the crucial information sources for defining the EOGRTS design and triggering the study itself.
- In biodegradation studies be sure that the microbial inoculum is not adapted, as this is not accepted. Adaptation of microbial inoculum means that inoculum is in contact with the tested substance before initiating the biodegradation test. Aeration and washing with mineral media is not regarded as inoculum adaptation
- Identify degradation products and report them accordingly. Information on degradation products is generally obtained from simulation tests. Conduct additional testing for these products if they can pose a risk or are expected to be of otherwise high concern (e.g. PBT/vPvB).
- For simulation testing for water, soil and sediment the recommended test guidelines are OECD TG 307, TG 308 and TG 309. STP simulation test (e.g. OECD TG 303 or OECD TG 314) are not appropriate as a sole source of information top conclude if a substance fulfil the P/vP criteria.
- In the assessment of persistency and bioaccumulation consider also each relevant degradation/transformation product and constituent/impurity/additive present in concentration at or above 0.1% (w/w) or, if not technically feasible, in concentrations as low as technically quantifiable shall be assessed. Alternatively, provide a justification for why these are not relevant for the PBT/vPvB assessment.
- For all aquatic studies always provide a reliable analytical monitoring of exposure concentrations
- Provide adequate information on the physico-chemical and fate properties of the test material. If required, follow the specific requirements applicable to difficult to test substances (OECD Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures).
- OECD TG 204 (Fish, Prolonged Toxicity Test: 14-Day Study) cannot be considered as suitable long-term test. This study is regarded as a prolonged toxicity study with fish mortality as the major endpoint examined.
- The fish early-life stage (FELS) toxicity test (test method OECD TG 210) is recommended for examining long-term fish toxicity. The test covers several life stages of the fish from the newly fertilised egg, through hatch to early stages of growth and is appropriate for examining the potential toxic effects of substances which are expected to cause effects over a longer exposure period, or which require a longer time to reach a steady state.
- Use the Equilibrium Partitioning Method (EPM) to predict toxicity to terrestrial organisms only when effects are observed in the aquatic toxicity tests. If a substance does not show effects in the aquatic toxicity tests, this method cannot be used.
- For substances that have a high potential to adsorb to soil or that are very persistent (Log Kow >5 and/or DT50 >180 days or in absence of DT50 the substance is not readily biodegradable), long-term terrestrial toxicity testing according to Annex X is needed instead of short-term testing, even if substance tonnage is at Annex IX (100-1000t/y). If inhibition of sewage sludge microbial activity has been observed, a test on the soil microbial community according to Annex IX section 9.4.3, should be considered either by testing or by providing a specific justification for adaptation. The nitrogen transformation test (OECD 216) is considered sufficient to fulfil the information requirement of Effects on soil micro-organisms (Annex IX, Section 9.4.2.) for most non-agrochemicals. For agrochemicals also OECD 217 is needed.