PART Igeneral provisions relating to labels
Labelling particulars for dangerous substances
1.—(1) In the case of a dangerous substance which is listed in the approved supply list, the particulars to be shown on the label in accordance with regulation 8(2)(c) shall be the particulars specified for that dangerous substance in the relevant entry in Part I of that list.
(2) Subject to paragraph 4, in the case of a dangerous substance which is not listed in the approved supply list, the particulars required to be shown on the label in accordance with regulation 8(2)(c) shall be determined from the classification of the substance in accordance with regulation 4 in conjunction with the approved classification and labelling guide.
Labelling particulars for dangerous preparations
2.—(1) Subject to paragraphs 3 and 4, the provisions of this paragraph shall have effect in relation to the labelling of dangerous preparations.
(2) Subject to sub-paragraph (4), the particulars relating to chemical name required to be shown on the label in accordance with regulation 8(3)(c)(i) shall be shown according to the following rules –
(a)in the case of a dangerous preparation classified as requiring the indication of danger T+, T or Xn, only substances requiring those indications of danger present in the dangerous preparation in concentrations equal to or greater than –
(i)the lowest limit (the Xn limit) for the substance laid down in Part I of the approved supply list, or
(ii)where there is no such limit, the relevant limit laid down in Part II of Schedule 3,
have to be taken into consideration;
(b)in the case of a dangerous preparation classified as requiring the indication of danger C, only substances requiring that indication of danger present in the dangerous preparation in concentrations equal to or greater than –
(i)the lowest limit (the Xi limit) for the substance laid down in Part I of the approved supply list, or
(ii)where there is no such limit, the relevant limit laid down in Part II of Schedule 3,
have to be taken into consideration;
(c)if the dangerous preparation is assigned one or more of the following danger categories:
carcinogen category 1, 2 or 3,
mutagen category 1, 2 or 3,
toxic for reproduction category 1, 2, or 3,
very toxic, toxic or harmful due to non-lethal effects after a single exposure,
toxic or harmful due to severe effects after repeated or prolonged exposure,
sensitising,
the name of any substance causing the dangerous preparation to be so assigned shall be referred to;
(d)as a consequence of the provisions set out in paragraphs (a) to (c), the name of any substance which led to the classification of the dangerous preparation in the following danger categories:
explosive,
oxidising,
extremely flammable,
highly flammable,
flammable,
irritant,
dangerous for the environment,
need not be referred to on the label unless so required by paragraph (a), (b) or (c).
(3) The chemical name referred to in sub-paragraph (2) shall be –
(a)in the case of a substance listed in Part I of the approved supply list, the name or one of the names under which that substance is listed; or
(b)in the case of a substance not so listed, an internationally recognised name.
(4) For the purpose of labelling, no account shall be taken of a substance in the dangerous preparation where the concentration of that substance is less than the concentration referred to in paragraph 22(1) of Part I of Schedule 3.
(5) Subject to sub-paragraph (4), the particulars to be shown on the label in accordance with regulation 8(3)(c)(ii), (iii) and (iv) shall be determined from the classification of the dangerous preparation made in accordance with regulation 4 in conjunction with the approved classification and labelling guide.
(6) As a general rule, a maximum of four chemical names shall suffice to identify the substances primarily responsible for the major health hazards which have given rise to the classification and the choice of the corresponding risk phrases – although in some cases more than four chemical names may be necessary.
Confidentiality of chemical names
3.—(1) Subject to sub-paragraph (2), where the supplier of a dangerous preparation is able to demonstrate to the Executive that the disclosure on the label or safety data sheet of the chemical identity of a substance which is exclusively classified as –
(a)irritant with the exception of those assigned R41 or irritant in combination with one or more of the other properties mentioned in paragraph 2(2)(d); or
(b)harmful or harmful in combination with one or more of the properties mentioned in paragraph 2(2)(d) presenting acute lethal effects alone,
will put at risk the confidential nature of his intellectual property, he shall, in accordance with the provisions of Annex VI to Council Directive 1999/45/EC(1), be permitted to 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.
(2) The derogation in sub-paragraph (1) shall not apply in respect of a substance which has been assigned a Community exposure limit.
(3) Where a supplier wishes to take advantage of the derogation contained in sub-paragraph (1), he shall make application to the Executive accordingly, enclosing the information specified in Annex VI to Council Directive 1999/45/EC.
(4) The Executive may require such further information from the supplier as is necessary to determine the validity of an application made under sub-paragraph (3).
(5) Regulation 18 of the NONS Regulations (which relates to confidentiality of information notified) shall apply to information provided in accordance with sub-paragraph (2) as it applies to information notified under those Regulations.
Indications of danger and symbols for dangerous substances and dangerous preparations
4.—(1) Except in the case of a dangerous substance which is listed in the approved supply list, where a dangerous substance or dangerous preparation is required to have more than one indication of danger in either of the following groups listed in decreasing order of severity, namely –
(a)explosive, oxidising, extremely flammable and highly flammable; or
(b)very toxic, toxic, corrosive, harmful and irritant,
only one of the indications of danger with its symbol from each group corresponding to the most severe indication of danger in that group need be shown.
(2) The risk phrases R12 (extremely flammable) and R11 (highly flammable) need not be used if they repeat the indication of danger shown on the label.
O.J. No. L200, 30.7.1999, p. 1.