ANNEX ISupplementary provisions
ANNEX I Part 1 of Annex I to Regulation (EC) No 1272/2008 is amended as follows: (1) section 1.1.1.3 is replaced by the following: ‘1.1.1.3. A weight of evidence determination means that all available information bearing on the determination of hazard is considered together, such as the results of suitable in vitro tests, relevant animal data, human experience such as occupational data and data from accident databases, epidemiological and clinical studies and well-documented case reports and observations. For substances, information from the application of the category approach (grouping, read-across) and (Q)SAR results are also considered. The quality and consistency of the data shall be given appropriate weight. Information on substances related to the substance being classified shall be considered, where appropriate. Information on substances or mixtures related to the mixture being classified shall be considered in accordance with Article 9(4). Information on the site of action and the mechanism or mode of action found in study results shall also be considered. Both positive and negative results shall be assembled together in a single weight of evidence determination.’; (2) section 1.2.1.4 is replaced by the following: ‘1.2.1.4. The dimensions of the label and of each pictogram, and the font size of letters shall be as follows: Table 1.3 Minimum dimensions of labels and pictograms and minimum font size Capacity of the package Dimensions of the label (in millimetres) for the information required by Article 17 Dimensions of each pictogram (in millimetres) Minimum font size (x-height in millimetres) Not exceeding 0,5 litres If possible, at least 52×74 Not smaller than 10×10 If possible, at least 16×16 1,2 Greater than 0,5 litres but not exceeding 3 litres 1,4 Greater than 3 litres but not exceeding 50 litres At least 74×105 At least 23×23 1,8 Greater than 50 litres but not exceeding 500 litres At least 105×148 At least 32×32 2,0 Greater than 500 litres At least 148×210 At least 46×46 2,0 ’; (3) the following section is added: ‘1.2.1.5. The text on the label shall have the following characteristics: (a) printed in black on a white background; (b) the distance between two lines shall be at least 120 % of the font size; (c) a single font that is easily legible and without serifs shall be used; (d) the letter spacing shall be appropriate for the selected font to be easily legible. For the labelling of inner packaging where the contents do not exceed 10 ml, the font size may be smaller than indicated in Table 1.3, as long as it remains easily legible, where it is deemed important to place the most critical statement, such as a hazard statement or EUH statement, and where the outer packaging meets the requirements of Article 17.’ (4) the following section is added: ‘1.2.1.6. Fold-out labels 1.2.1.6.1. The front page of the fold-out label shall include at least the following elements: (i) the name, address and phone number of suppliers; (ii) nominal quantity of the substance or mixture in the package made available to the general public, unless this quantity is specified elsewhere on the package; (iii) the product identifiers in accordance with Article 18(2) for substances and Article 18(3)(a) for mixtures in all languages of the label that are used in the inside pages; (iv) where applicable, the hazard pictograms; (v) where applicable, the signal words in all languages of the label that are used in the inside pages; (vi) where applicable, the unique formula identifier, unless printed or affixed on the inner packaging in accordance with Part A, point 5.3, of Annex VIII to this Regulation; (vii) a reference to the full safety information inside the fold-out label in all languages of the label or a symbol to inform a user that the label can be opened and to illustrate that additional information is available on inside pages; (viii) an abbreviation of the language (country code or language code) for all the languages that are used in the inside pages. 1.2.1.6.2. The inner pages of the fold-out label shall contain all the label elements provided for in Article 17(1), except for the hazard pictogram and the supplier identification, in each of the languages mentioned on the front page and grouped by language, using the language abbreviation (country code or language code). 1.2.1.6.3. The back page of the fold-out label shall contain all the label elements provided on the front page, except for the abbreviations of the languages that are used in the inside pages.’; (5) the following section is added: ‘1.3.7. Ammunition In the case of ammunition that is a substance or mixture and that is shot through a firearm, the label elements may be provided on the intermediate packaging instead of on the inner packaging, or, if there is no intermediate packaging, on the outer packaging.’; (6) the heading of section 1.5.1 is replaced by the following: ‘1.5.1. Exemptions from Article 31 in accordance with Article 29(1) ’; (7) section 1.5.1.1 is replaced by the following: ‘1.5.1.1. Where Article 29(1) applies, the label elements referred to in Article 17 may be provided on a tie-on tag or on an outer packaging.’; (8) section 1.5.1.2 is replaced by the following: ‘1.5.1.2. Where section 1.5.1.1 applies, the label on any inner packaging shall contain at least the hazard pictograms, the signal words, the product identifier referred to in Article 18(2) for substances or the trade name or designation referred to in Article 18(3), point (a) for mixtures, and the name and telephone number of the suppliers of the substance or mixture.’; (9) the heading of section 1.5.2 is replaced by the following: ‘1.5.2. Exemptions from Article 17 in accordance with Article 29(2) ’; (10) section 1.5.2.4.1 is replaced by the following: ‘1.5.2.4.1. The label elements required by Article 17 may be omitted from the inner packaging where the contents of the inner packaging do not exceed 10 ml and any of the following applies: (a) the substance or mixture is placed on the market for supply to a distributor or downstream user for scientific research and development or quality control analysis and the inner packaging is contained within outer packaging that meets the requirements set out in Article 17; (b) the substance or mixture does not require labelling in accordance with Part 1 or 2 of Annex II and is not classified in any of the following hazard classes and categories: (i) acute toxicity, any category; (ii) specific target organ toxicity – single exposure, categories 1 and 2; (iii) specific target organ toxicity – repeated exposure, any category; (iv) skin corrosion, category 1, any sub-category; (v) serious eye damage, category 1; (vi) respiratory sensitisation, any category; (vii) aspiration hazard; (viii) germ cell mutagenicity, any category; (ix) carcinogenity, any category; (x) reproductive toxicity, any category; (xi) endocrine disruption for human health, any category; (c) the substance or mixture requires labelling in accordance with Part 1 or 2 of Annex II but is not classified in any of the hazard classes and categories referred to in point (b) of this section and has an inner packaging that is contained within outer packaging that meets the requirements set out in Article 17.’; (11) the following section is added: ‘1.6. Label elements that may be provided on a digital label only Supplemental information referred to in Article 25(3).’.