ANNEXU.K.FRAMEWORK
ECOLOGICAL CRITERIAU.K.
1.Toxicity to aquatic organismsU.K.
The critical dilution volume toxicity (CDVtox) is calculated for each ingredient (i) using the following equation:
where weight (i) is the weight of the ingredient (in grams) per functional unit (for all-purpose cleaners) or per 100 g of product (cleaners for sanitary facilities). DF (i) is the degradation factor and TF chronic (i) is the toxicity factor of the ingredient (in milligram/litre).
The values of DF and TF chronic shall be as given in the detergent ingredient database list-part A (DID list-part A) (Appendix I). If the ingredient in question is not included in the DID list-part A, the applicant shall estimate the values following the approach described in the DID list-part B (Appendix 1). The CDVtox is summed for each ingredient, making the CDVtox for the product.
For all-purpose cleaners, the CDVtox for the product shall not exceed 20 000 l/functional unit.
For cleaners for sanitary facilities, the CDVtox for the product shall not exceed 100 000 l per 100 g product.
For window cleaners, the CDVtox for the product shall not exceed 5 000 l per 100 g product.
Assessment and verification: the exact formulation of the product shall be provided to the competent body, together with the details of the CDVtox calculations showing compliance with this criterion.
2. Biodegradability of surfactants U.K.
(a)Ready biodegradability (aerobic)U.K.
Each surfactant used in the product shall be readily biodegradable.
Assessment and verification: the exact formulation of the product as well as a description of the function of each ingredient shall be provided to the competent body. The DID list-part A (Appendix I) indicates whether a specific surfactant is aerobically biodegradable or not (the surfactants with an entry of ‘R’ in the column on aerobic biodegradability are readily biodegradable). For surfactants which are not included in the DID list-part A, the relevant information from literature or other sources, or appropriate test results, showing that they are aerobically biodegradable shall be provided. The tests for ready biodegradability shall be as referred to in Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents(1). Surfactants shall be considered as readily biodegradable if the level of biodegradability (mineralisation) measured according to one of the five following tests is at least 60 % within 28 days: CO2 headspace test (OECD 310), carbon dioxide (CO2) evolution modified Sturm test (OECD 301B; Council Directive 67/548/EEC(2) Annex V.C.4-C), closed bottle test (OECD 301D; Directive 67/548/EEC Annex V.C.4-E), manometric respirometry (OECD 301F; Directive 67/548/EEC Annex V.C.4-D), or MITI (I) test (OECD 301C; Directive 67/548/EEC Annex V.C.4-F), or their equivalent ISO tests. Depending on the physical characteristics of the surfactant, one of the following tests might be used to confirm ready biodegradability, if the level of biodegradability is at least 70 % within 28 days: dissolved organic carbon DOC die-away (OECD 301A; Directive 67/548/EEC Annex V.C.4-A) or modified OECD screening DOC die-away (OECD 301E; Directive 67/548/EEC Annex V.C.4-B), or their equivalent ISO tests. The applicability of test methods based on measurement of dissolved organic carbon needs to be appropriately justified as these methods could give results on the removal and not on the biodegradability. Pre-adaptation is not to be used in tests for aerobic ready biodegradability. The 10 days window principle shall not apply.
(b)Anaerobic biodegradabilityU.K.
Each surfactant used in the product shall be biodegradable under anaerobic conditions.
Assessment and verification: the exact formulation of the product as well as a description of the function of each ingredient shall be provided to the competent body. The DID list-part A (Appendix I) indicates whether a specific surfactant is anaerobically biodegradable or not (the surfactants with an entry of ‘Y’ in the column on anaerobic biodegradability are biodegradable under anaerobic conditions). For surfactants which are not included in the DID list-part A, the relevant information from literature or other sources, or appropriate test results, showing that they are anaerobically biodegradable shall be provided. The reference test for anaerobic degradability shall be OECD 311, ISO 11734, ECETOC No 28 (June 1988) or an equivalent test method, with the requirement of a minimum of 60 % ultimate degradability under anaerobic conditions. Test methods simulating the conditions in a relevant anaerobic environment may also be used to document that 60 % ultimate degradability has been attained under anaerobic conditions (see Appendix II).
3.Dangerous, hazardous or toxic substances or preparationsU.K.
(a)The following ingredients shall not be included in the product, either as part of the formulation or as part of any preparation included in the formulation:U.K.
Alkyl phenol ethoxylates (APEOs) and derivatives thereof,
EDTA (ethylene-diamine-tetra-acetate) and its salts,
NTA (nitrilo-tri-acetate),
Nitromusks and polycyclic musks, including for example:
Musk xylene: 5-tert-butyl-2,4,6-trinitro-m-xylene,
Musk ambrette: 4-tert-butyl-3-methoxy-2,6-dinitrotoluene,
Moskene: 1,1,3,3,5-pentamethyl-4,6-dinitroindan,
Musk tibetine: 1-tert-butyl-3,4,5-trimethyl-2,6-dinitrobenzene,
Musk ketone: 4’-tert-butyl-2’,6’-dimethyl-3’,5’-dinitroacetaphenone,
HHCB (1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta(g)-2-benzopyran),
AHTN (6-Acetyl-1,1,2,4,4,7-hexamethyltetralin).
Assessment and verification: the applicant shall provide a declaration supported by declarations from manufacturers of ingredients, as appropriate, confirming that the listed substances have not been included in the product.
(b)Quaternary ammonium salts that are not readily biodegradable shall not be used, either as part of the formulation or as part of any preparation included in the formulation.U.K.
Assessment and verification: the applicant shall provide documentation showing the biodegradability of any quaternary ammonium salt used.
(c)No ingredient (substance or preparation) shall be included in the product that is classified, with any of the following risk phrases, or any combination thereof, in accordance with Directive 67/548/EEC and its amendments or Directive 1999/45/EC of the European Parliament and of the Council(3) and its amendments:U.K.
R31 (contact with acid liberates toxic gas),
R40 (limited evidence of a carcinogenic effect),
R45 (may cause cancer),
R46 (may cause heritable genetic damage),
R49 (may cause cancer by inhalation),
R68 (possible risks of irreversible effects)
R50-53 (very toxic to aquatic organism and may cause long term adverse effects in the aquatic environment),
R51-53 (toxic to aquatic organism and may cause long term adverse effects in the aquatic environment),
R59 (dangerous to the ozone layer),
R60 (may impair fertility),
R61 (may cause harm to the unborn child),
R62 (possible risk of impaired fertility),
R63 (possible risk of harm to the unborn child),
R64 (may cause harm to breastfed babies).
Specific requirements are prescribed for biocides, either as part of the formulation or as part of any preparation included in the formulation (see criterion on biocides below).
The above requirements shall apply to each ingredient (substance or preparation) that exceeds 0,01 % by weight of the final product. This includes also each ingredient of any preparation used in the formulation that exceeds 0,01 % by weight of the final product.
Assessment and verification: copies of the material safety data sheets shall be provided for all ingredients (whether substances or preparations). A declaration prepared by the manufacturer of ingredients and showing compliance with this criterion shall be provided by the applicant.
4.BiocidesU.K.
The product may only include biocides in order to preserve the product, and in the appropriate dosage for this purpose alone. This does not refer to surfactants, which may also have biocidal properties.
Assessment and verification: copies of the material safety data sheets of any preservatives added shall be provided, together with information on their exact concentration in the product. The manufacturer or supplier of the preservatives shall provide information on the dosage necessary to preserve the product.
It is prohibited to claim or suggest on the packaging or by any other communication that the product has an antimicrobial action.
Assessment and verification: the texts and layouts used on each type of packaging and/or an example of each different type of packaging shall be provided to the competent body.
Biocides, either as part of the formulation or as part of any preparation included in the formulation, that are used to preserve the product and that are classified with R50-53 or R51-53 risk phrases, in accordance with Directive 67/548/EEC and its amendments or Directive 1999/45/EC, are permitted but only if they are not potentially bioaccumulative. In this context, a biocide is considered to be potentially bioaccumulative if the log Pow (log octanol/water partition coefficient) ≥3,0 (unless the experimentally determined BCF ≤100).
The concentration of biocides in the final product shall not exceed the maximum authorised concentration in Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products and its subsequent amendments.
Assessment and verification: copies of the material safety data sheets shall be provided for all biocides, together with a documentation of the concentrations of the biocides in the final product.
5.Dyes or colouring agentsU.K.
Any dyes or colouring agents used in the product must be permitted by Council Directive 76/768/EEC relating to cosmetic products(4) and its subsequent amendments, or must be permitted by European Parliament and Council Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs(5) and its subsequent amendments, or must be characterised by environmental properties that do not imply classification with R50-53 or R51-53 risk phrases, in accordance with Directive 67/548/EEC and its amendments.
Assessment and verification: a declaration of compliance with this criterion shall be provided to the competent body, together with a full list of all dyes or colouring agents used.
6.FragrancesU.K.
The product shall not contain perfumes containing nitro-musks or polycyclic musks (as specified in the criterion 3(a).
Any ingredients added to the product as a fragrance must have been manufactured and/or handled in accordance with the code of practice of the International Fragrance Association.
Assessment and verification: a declaration of compliance with each part of this criterion shall be provided to the competent body.
7.Sensitising substancesU.K.
The product shall not be classified with R42 (may cause sensitisation by inhalation) and/or R43 (may cause sensitisation by skin contact) risk phrases, in accordance with Directive 1999/45/EC and its amendments.
The concentration of any substance or ingredient classified with R42 (may cause sensitisation by inhalation) and/or R43 (may cause sensitisation by skin contact) risk phrases, in accordance with Directive 67/548/EEC and its amendments or Directive 1999/45/EC and its amendments, shall not exceed 0,1 % by weight of the final product.
Assessment and verification: the exact concentrations of all ingredients that are classified as R42 and/or R43 shall be provided to the competent body, together with copies of the material safety data sheets.
8.Volatile organic compoundsU.K.
The product shall not contain more than 10 % (by weight) of volatile organic compounds with a boiling point lower than 150 oC.
Assessment and verification: copies of the material safety data sheets of each organic solvent together with details of the calculations of the total volatile organic compounds with a boiling point lower than 150 oC shall be provided by the applicant.
9.PhosphorusU.K.
The total quantity of elemental phosphorous in the product shall be calculated per functional unit (for all-purpose cleaners) or per 100 g of product (cleaners for sanitary facilities) taking into account all ingredients containing phosphorus (e.g. phosphates and phosphonates).
For all-purpose cleaners, the total phosphorus content (P) shall not exceed 0,02 g/functional unit.
For cleaners for sanitary facilities, the total phosphorus content (P) shall not exceed 1,0 g/100 g of product.
Ingredients used in window cleaning products must not contain phosphorus.
Assessment and verification: the exact formulation of the product shall be provided to the competent body, together with the details of the calculations showing compliance with this criterion.
10.Packaging requirementsU.K.
Sprays containing propellants must not be used.
Plastic materials that are used for the main container shall be marked according to European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste(6), or DIN 6120 Parts 1 and 2 in connection with DIN 7728 part 1.
If the primary packaging is made of recycled material, any indication of this on the packaging shall be in conformity with the ISO 14021 standard ‘Environmental labels and declarations — Self declared claims (type II environmental labelling)’.
The primary packaging parts shall be easily separable into mono-material parts.
Assessment and verification: data on the packaging, and/or a sample thereof if appropriate, shall be provided to the competent body, together with a declaration of compliance with each part of this criterion.
Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ L 196, 16.8.1967, p. 1).
Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (OJ L 200, 30.7.1999, p. 1).