Evaluation criteria of cleaning, disinfection and hygiene products in the Input List for Organic Agriculture and the Input List for Organic Processing

Transcription

1 Evaluation criteria of cleaning, disinfection and hygiene products in the Input List for Organic Agriculture and the Input List for Organic Processing First edition: Revised: (Leopold, J.; Milan, M.) (Leopold, J.; Milan, M.) Research Institute of Organic Agriculture (FiBL) P.O. Box D Frankfurt am Main Tel Fax

2 Content 1. Introduction Scope of application Administrative requirements Criteria for registration Ingredients Active ingredients for products for cleaning and disinfection of... buildings and installations for animal production Negative list Criteria concerning ecotoxicity and biodegradability Calculation of the critical dilution volume (CDV) Maximum limits for the CDV value Calculation example for the critical dilution volume (CDV) Other excluded substances Introduction Annex VII of Reg. 889/2008 contains a list of substances allowed for use in buildings and installations for livestock production and in aquaculture. For cleaning and disinfection of teats and milking equipment, Annex VII of Reg. 889/2008 makes no restrictions. For the evaluation of cleaning, disinfection and hygiene products a negative list of substances has been drawn up. These substances are not permitted in cleaning and disinfection products (C&D products) due to their toxicity and environmental impact. For the technical justification of the classification, appropriate substance descriptions were prepared within the framework of a scientific project for the processing sector. Manufacturers/marketers of C&D products must ensure that these unauthorized substances (e.g. non-degradable quaternary ammonium compounds) are not present in the product and secure this statement by suitable measures (e.g. analysis). The examination of the degradability of the products based on OECD tests is nowadays only carried out by a few manufacturers. OECD tests are therefore no longer suitable as the only criteria for the inclusion of products in the input list. With regard to the assessment of ecotoxicity and degradability, the system of the EU Ecolabel is therefore used ( (exception: udder hygiene and udder care products). 2. Scope of application These criteria apply to the organic input list for organic processing in Germany from the 2017 edition onwards. They are also applicable for cleaning and disinfection products for milking equipment as well as products for cleaning and disinfection of buildings and installations for animal production. In the future, these criteria should also be used for the evaluation of products for plant production (greenhouses, farm storage, etc.). With the Page2

3 exception of point 4.2 "Criteria concerning ecotoxocity and degradability", the criteria also apply to udder hygiene and udder care products. Therefore the critical dilution volume (CDV) is not relevant for the approval of udder hygiene and udder care products. Instead hazard statements (H-statements) as defined in point 4.3 will be applied. 3. Administrative requirements The following applies to all C&D product categories: The full formulation has to be submitted (100%). For products that are subject to registration under the Biocidal Products Registration Regulation (Biozidmeldeverordnung) an official authorization document (e.g. copy of the BAuA registration) has to be submitted. A proof of effectiveness is not required. Listings according to DVG, IHO, DLG or others are displayed in the list, if available. 4. Criteria for registration 4.1 Ingredients In principle, all ingredients are approved for all applications unless they are on the negative list (Section 4.2.1). For application areas regulated in the EU Organic Regulation, the requirements listed there apply Active ingredients for products for cleaning and disinfection of buildings and installations for animal production Active ingredients in products for cleaning and disinfection of buildings and installations for animal production have to comply with the EU Organic Regulation 889/2008 Annex VII Negative list The following substances are not permitted: Tensides Acids (incl. their salts) Alkylphenolethoxylate (APEO) Fluorosurfactants Quaternary ammonium compounds (QAC s) Phosphoric acid (previously permitted as acid for the disinfection of milking equipment, should be excluded in the long-term due to eutrophication of aquatic environments. For all areas of application, transitional periods will apply until the end of 2020) Phosphates Phosphoric acid esters Page3

4 Phosphonic acid (exception: up to max. 1 % permitted as stabilizer for peracetic acid and hydrogen peroxide with a transitional period until from no further listing possible) Phosphonic acid ester / Polyphosphonates Phthalic acid esters / Phthalates Persistent long-chain polycarboxylic acids (short-chain, such as ascorbic acid, tartaric acid, citric acid, are permitted) Boron containing acids and their salts Bases Other ingrediants (none) Biphenyl-2-ol Chlorine releasing substances / Active chlorine / Electrolyte water Triclosan Perchlorates Ethylenediaminetetraacetic acid (EDTA), Diethylenetriaminepentaacedic acid (DTPA), Nitrilotriacetic acid (NTA) and their salts as well as other comparable chemical-synthetic chelators Formaldehyde und formaldehyde releasing substances Ammonia and ammonia releasing substances Amino-alcohols (monoethanolamine, diethanolamine) Intentionally added components with a particle size of < 0.3 µm (nanoparticles) Enzymes (if in the future processes with enzymes will be developed, tested and officially recognized for the food sector, the list can be reviewed) Bromine compounds 4.2 Criteria concerning ecotoxicity and biodegradability The assessment of ecotoxicity and biodegradation is based on the EU Ecolabel system ( The so-called critical dilution volume (CDV) is calculated using the DID list (Detergents Ingredients Database). The calculation of the CDV as a listing criteria is done for all categories except animal care products (including udder hygiene and udder care products). Page4

5 4.2.1 Calculation of the critical dilution volume (CDV) The method for calculating the chronic Critical Dilution Volume (CDV) is explained in the EU-Ecolabel 1. The following information is required to calculate the CDV: Full formulation of the product (all components including) Dosage of the product (normal and maximum dosage) Degradability and toxicity value (from DID list). If substance is missing on the DID list A, the corresponding values are calculated according to DID list B. In all cases the worst case -scenario is used. The formula for calculating the CDV is as follows: wwwwwwwwwwww(ii) DDDD(ii) CCCCCC = Ʃ CCCCCC (ii) = Ʃ DDDDDDDDDDDD xx TTTT(ii) CDV Weight DF (i) TF Dosage (i) = Critical dilution volume of the product = Quantity of the individual substance in 100g of the product = Degradation factor (from DID list). = Toxicity factor (from DID list) = Dosage of the product in % (manufacturer`s declaration) = Determined ingredient of the product Maximum limits for the CDV value The maximum limits for the CDV are set as follows: Dosage CDV max. Normal dosage: regular use (often daily) Maximum dosage: occasional use (e.g. 1x a week) Calculation example for the critical dilution volume (CDV) Formulation example: Full formulation including quantities Components DID-No. Quatity per 100g Citric acid g Fatty alcohol ethoxylate (C12-18), >2,5-5 EO g Ethanol g Water - 63 g Dosage: Normal dosage: 2-3 %. In the sense of a worst case scenario, 3 % is calculated. Maximum dosage: 10 %. 1 COMMISSION DECISION (EU) 2017/1217 of 23 June 2017 establishing the EU Ecolabel criteria for hard surface cleaning products Page5

6 Calculation of the KDV for all components Components Quantity per 100g Degradability (DF) Toxicity (TF) CDV per component* Citric acid Fatty alcohol ethoxylate (C12-18) Ethanol Water Sum of the CDV of all components * CDV per component = Quantity x DF / TF Calculation of the CDV for the applications of the product Application CDV of all components Dosage CDV* Normal application %: Max. application %: * CDV = Sum of the CDV of all components x 1000 x Dosage Evaluation of the test formulation The calculated CDV of meets the requirements for normal dosages (<10.000). The calculated CDV of meets the requirements for maximum dosage (<20.000). 4.3 Other excluded substances For animal care products (including udder hygiene and udder care products), substances classified according to Regulation (EC) No 1272/2008 with the following hazard statements are excluded: H300 H310 H311 H317 H330 H340 H350 H350i H360 H360F H360D H360FD H360Fd H360Df H362 H370 H372 H410 H411 H420 EUH070 The substances authorised under (EC) No 889/2008 Annex VII are permitted for the uses described there, irrespective of their hazard statement. Natural plant extracts and oils may be used up to a maximum of 5 % in the formulation, irrespective of their hazard statement. FiBL has the right to exclude other substances or products from all categories if there is a reasonable scientific suspicion that they could have serious adverse effects on human health and/or the environment (e.g. carcinogenic, mutagenic, toxic to reproduction, endocrine disrupting, persistent). Page6