Introductory Guidance on the CLP Regulation - ECHA - Europa

Basic guidance to Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of substances and mixtures
Testing for health and environmental hazards
CLP does not oblige you to perform new testing. However, you may perform new
testing provided that you have exhausted all other means of generating information,
including by applying the rules provided for in section 1 of Annex XI to REACH (CLP
Article 8). These rules refer to the use of existing data, use of data from tests not
carried out according to the principles of good laboratory practice, use of historical
human data, application of weight of evidence and use of (Q)SAR’s 4 , in-vitro methods
and read-across. Expert judgement should be used in order to apply the criteria, for
example to evaluate available test data that cannot be applied directly to the criteria or
to exploit available data on mixtures which are similar to the one to be classified (CLP
Article 9). Animal testing should only be undertaken when no other alternatives are
available that provide adequate reliability and quality of data. New testing not
involving animals may be performed where this warrants a more appropriate
classification, e.g. in case of transformation/dissolution testing for the aquatic hazard
classification of metals and sparingly soluble metal compounds. Testing on humans is
not allowed for the purposes of the CLP Regulation. However, data obtained from
clinical or epidemiological studies or scientifically valid case studies may be used.
Testing on non-human primates is prohibited (CLP Article 7).
In general, any new testing shall be carried out in accordance with the test methods
set out in Regulation (EC) No 440/2008; alternatively, it can be based on sound
scientific principles that are internationally recognised or on internationally validated
methods.
Testing shall be carried out on the substance or mixture in the form(s) or physical
state(s) in which it is placed on the market and in which it can reasonably be expected
to be used (for further guidance see Part 1.2 of Module 2). Moreover, new testing
involving animals must be carried out in compliance with the principles of good
laboratory practice and respect the rules of Directive 86/609/EEC. Normally, it will be
necessary for you to outsource such testing.
For mixtures, the same rules apply as for substances – where data are already
available on the mixture as a whole, this should primarily be considered. However, in
relation to the carcinogenic, mutagenic or toxic to reproduction (CMR) properties of a
mixture, the classification shall normally be based on the classification of the
ingredient substances, applying the relevant concentration thresholds. Only in
exceptional cases you may use available test data on the mixture itself, i.e. where
these indicate CMR properties that have not been identified from the individual
ingredient substances (CLP Article 6(3)). Mixture classification for the aquatic hazard
taking account of biodegradation and bioaccumulation should be based on the
4
(Q)SAR stands for qualitative or quantitative structure-activity relationship.
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