[X1ANNEX II U.K. GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS

Editorial Information

3. COMPOSITION/INFORMATION ON INGREDIENTS U.K.

The information given shall enable the recipient to identify readily the hazards of the components of the preparation. The hazards of the preparation itself shall be given under heading 2.

3.1. It is not necessary to give the full composition (nature of the ingredients and their concentration), although a general description of the components and their concentrations can be helpful. U.K.

3.2. For a preparation classified as dangerous according to Directive 1999/45/EC, the following substances shall be indicated, together with their concentration or concentration range in the preparation: U.K.

(a)

substances presenting a health or environmental hazard within the meaning of Directive 67/548/EEC, if they are present in concentrations equal to or greater than the lowest of:

  • the applicable concentrations defined in the table of Article 3(3) of Directive 1999/45/EC, or

  • the concentration limits given in Annex I to Directive 67/548/EEC, or

  • the concentration limits given in Part B of Annex II to Directive 1999/45/EC, or

  • the concentration limits given in Part B of Annex III Directive 1999/45/EC, or

  • the concentration limits given in Annex V to Directive 1999/45/EC, or

  • the concentration limits given in an agreed entry in the classification and labelling inventory established under Title XI of this Regulation;

(b)

substances for which there are Community workplace exposure limits, which are not already included under point (a);

(c)

substances that are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII, if the concentration of an individual substance is equal to or greater than 0,1 %.

3.3. For a preparation not classified as dangerous according to Directive 1999/45/EC, the substances shall be indicated, together with their concentration or concentration range, if they are present in an individual concentration of either: U.K.

(a)

≥ 1 % by weight for non-gaseous preparations and ≥ 0,2 % by volume for gaseous preparations and

(b)

≥ 0,1 % by weight and the substances are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII.

3.4. The classification (derived either from Articles 4 and 6 of Directive 67/548/EEC, from Annex I to Directive 67/548/EEC or from an agreed entry in the classification and labelling inventory established under Title XI of this Regulation) of the above substances shall be given, including the symbol letters and R phrases which are assigned in accordance with their physicochemical, human health and environmental hazards. The R phrases do not need to be written out in full here: reference shall be made to heading 16, where the full text of each relevant R phrase shall be listed. If the substance does not meet the classification criteria, the reason for indicating the substance in section 3 shall be described, such as ‘ PBT-substance ’ or ‘ substance with a Community workplace exposure limit ’ . U.K.

3.5. The name and the Registration number, assigned under Article 20(1) of this Regulation, EINECS or ELINCs number, if available, of the above substances shall be given in accordance with Directive 67/548/EEC. The CAS number and IUPAC name (if available) may also be helpful. For substances listed by a generic name, according to Article 15 of Directive 1999/45/EC or the footnote to Section 3.3 of this Annex, a precise chemical identifier is not necessary. U.K.

3.6. If, in accordance with the provisions of Article 15 of Directive 1999/45/EC or the footnote to Section 3.3 of this Annex, the identity of certain substances is to be kept confidential, their chemical nature shall be described in order to ensure safe handling. The name used shall be the same as that which derives from the above procedures.] U.K.

(1)

[X1Where the person responsible for placing the preparation on the market can demonstrate that the disclosure in the safety data sheet of the chemical identity of a substance which is exclusively classified as irritant with the exception of those assigned R41 or irritant in combination with one or more of the properties mentioned in point 2.3.4 of Article 10 of Directive 1999/45/EC, or harmful or harmful in combination with one or more of the properties mentioned in point 2.3.4 of Article 10 of Directive 1999/45/EC presenting acute lethal effects alone, will put at risk the confidential nature of his intellectual property, he may, in accordance with the provisions of Part B of Annex VI to Directive 1999/45/EC, refer to that substance either by means of a name that identifies the most important functional chemical groups, or by means of an alternative name.]

Editorial Information