Regulation (EC) No 1907/2006 of the European Parliament and of the CouncilShow full title

[X1 1.1. Use of existing data U.K.

1.1.1. Data on physical-chemical properties from experiments not carried out according to GLP or the test methods referred to in Article 13(3) U.K.

Data shall be considered to be equivalent to data generated by the corresponding test methods referred to in Article 13(3) if the following conditions are met:

(1)

adequacy for the purpose of classification and labelling and/or risk assessment;

(2)

sufficient documentation is provided to assess the adequacy of the study; and

(3)

the data are valid for the endpoint being investigated and the study is performed using an acceptable level of quality assurance.

1.1.2. Data on human health and environmental properties from experiments not carried out according to GLP or the test methods referred to in Article 13(3) U.K.

Data shall be considered to be equivalent to data generated by the corresponding test methods referred to in Article 13(3) if the following conditions are met:

(1)

adequacy for the purpose of classification and labelling and/or risk assessment;

(2)

adequate and reliable coverage of the key parameters foreseen to be investigated in the corresponding test methods referred to in Article 13(3);

(3)

exposure duration comparable to or longer than the corresponding test methods referred to in Article 13(3) if exposure duration is a relevant parameter; and

(4)

adequate and reliable documentation of the study is provided.

[F1 1.1.3. Historical human data U.K.

Historical human data, such as epidemiological studies on exposed populations, accidental or occupational exposure data and clinical studies, shall be considered.

The strength of the data for a specific human health effect depends, among other things, on the type of analysis and on the parameters covered and on the magnitude and specificity of the response and consequently the predictability of the effect. Criteria for assessing the adequacy of the data include:

(1)

the proper selection and characterisation of the exposed and control groups;

(2)

adequate characterisation of exposure;

(3)

sufficient length of follow-up for disease occurrence;

(4)

valid method for observing an effect;

(5)

proper consideration of bias and confounding factors; and

(6)

a reasonable statistical reliability to justify the conclusion.

In all cases adequate and reliable documentation shall be provided.

When nanoforms are covered by the registration the above approach shall address the nanoforms separately.] ]

Textual Amendments

F1 Substituted by Commission Regulation (EU) 2018/1881 of 3 December 2018 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances (Text with EEA relevance).

Editorial Information

X1 Substituted by Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Official Journal of the European Union L 396 of 30 December 2006).