Commission Regulation (EU) 2018/1881Show full title

8. Annex XI to Regulation (EC) No 1907/2006 is amended as follows: U.K.

(a)

In the introductory text, the following text is added after the last paragraph:

‘The requirements specific to nanoforms in this Annex are without prejudice to requirements applicable to other forms of a substance.’;

(b)

Point 1.1.3. is replaced by the following:

‘1.1.3. Historical human data

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.’;

(c)

Subsection 1.2. is replaced by the following:

‘1.2. Weight of evidence

There may be sufficient weight of evidence from several independent sources of information leading to the assumption/conclusion that a substance has or has not a particular dangerous property, while the information from each single source alone is regarded insufficient to support this notion.

There may be sufficient weight of evidence from the use of newly developed test methods, not yet included in the test methods referred to in Article 13(3) or from an international test method recognised by the Commission or the Agency as being equivalent, leading to the conclusion that a substance has or has not a particular dangerous property.

Where sufficient weight of evidence for the presence or absence of a particular dangerous property is available:

• further testing on vertebrate animals for that property shall be omitted,

• further testing not involving vertebrate animals may be omitted.

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.’;

(d)

Subsection 1.3. is replaced by the following:

‘1.3. Qualitative or Quantitative structure-activity relationship ((Q)SAR)

Results obtained from valid qualitative or quantitative structure-activity relationship models ((Q)SARs) may indicate the presence or absence of a certain dangerous property. Results of (Q)SARs may be used instead of testing when the following conditions are met:

• results are derived from a (Q)SAR model whose scientific validity has been established,

• the substance falls within the applicability domain of the (Q)SAR model,

• results are adequate for the purpose of classification and labelling and/or risk assessment, and

• adequate and reliable documentation of the applied method is provided.

The Agency in collaboration with the Commission, Member States and interested parties shall develop and provide guidance in assessing which (Q)SARs will meet these conditions and provide examples.

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

(e)

The last paragraph in Section 1.4 is replaced by the following:

‘Such confirmation may be waived if the following conditions are met:

(1)

results are derived from an in vitro method whose scientific validity has been established by a validation study, according to internationally agreed validation principles;

(2)

results are adequate for the purpose of classification and labelling and/or risk assessment; and

(3)

adequate and reliable documentation of the applied method is provided.

When nanoforms are covered by the registration the above approach in points (1) to (3) shall address the nanoforms separately.’;

(f)

The first paragraph in Section 1.5 is replaced by the following:

‘Substances whose physicochemical, toxicological and eco-toxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or “category” of substances. Application of the group concept requires that physicochemical properties, human health effects and environmental effects or environmental fate may be predicted from data for reference substance(s) within the group by interpolation to other substances in the group (read-across approach). This avoids the need to test every substance for every endpoint. The Agency, after consulting with relevant stakeholders and other interested parties, shall issue guidance on technically and scientifically justified methodology for the grouping of substances sufficiently in advance of the first registration deadline for phase-in substances.

When nanoforms are covered by the registration the above approach shall address the nanoforms separately. For grouping different nanoforms of the same substance the molecular structural similarities alone cannot serve as a justification.

If nanoforms covered by a registration are grouped or placed in a “category” with other forms, including other nanoforms, of the substance in the same registration the obligations above shall apply in the same manner.’