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Excluded and restricted substances The chemicals used in the formulation of the product may contribute significantly to the overall environmental impact of the lubricants. In order to apply a strict interpretation of the European regulation, the revision propose to restrict the European Ecolabel hazards at substance level; information on any substance (also formed after chemical reaction) at or above a concentration of 0,01% (w/w) in the final product shall be provided to the competent body, indicating: -


Trade name and/or chemical name (IUPAC)


- CAS or EC No - - -


- Fraction present (% w/w) Function and form present in the final product


Hazard-statements (depending of the H-phrases, the concentration limit is 0,01% (w/w), or ≤ 0,5 x final product classification limit or = to the final product classification limit)


- - - - -


The substance is not in the Union List of priority substances ((water policy Annex X to Directive 2000/60/EC amended N° 2455/2001/EC)


The substance in not in the OSPAR List of Chemicals


The substance is not in the list for Substances of Very High Concern (SVHCs)


The substance doesn’t contain organic halogen compounds or nitrite compounds


The substance doesn’t contain metal or metallic compounds with the exception of Na, K, Mg and Ca and, in case of thickeners, also Li and/or Al)


It concerns the substances intentionally added so the impurities stated in Safety Data Sheet (SDS) must be included. The substances present in the form of nanomaterials shall be clearly indicated as “nano”.


Where stricter than 0,01% (w/w), the generic or specific concentration limits shall take precedence. Where classification limit is mentioned, the maximum total concentration of all classified substances with a specific hazard statement shall be considered.


The final product shall not be classified and labelled as being acutely toxic, a specific target organ toxicant, a respirometry or skin sensitiser, carcinogenic, mutagenic or toxic for reproduction, or hazardous to aquatic environment (Annex I (EC) No 1272/2008.


The applicant shall provide a signed declaration of compliance with SDS of the final product, SDS of


26 LUBE MAGAZINE NO.148 DECEMBER 2018


QSARs (Quantitative Structure – Activity Relationship) shall be accepted to fill the gaps in only one of the trophic levels.


The requirements for aquatic toxicity on an hydraulic fluid (ALL) are:


For freshly prepared lubricant: On 3 trophic levels : daphnia, algae and fish for acute toxicity (LC50/EC50 or LL50/EL50 if WAF) and, if acute toxicity data are missing, daphnia and fish for chronic toxicity (NOEC/NOEL)


-


> 100 mg/l for acute aquatic toxicity, or - > 10 mg/l for chronic aquatic toxicity


For each main component (> 5% weight of the lubricant): On 2 trophic levels : daphnia and algae for acute toxicity (LC50/EC50 or LL50/EL50 if WAF) and, if acute toxicity data are missing, daphnia and fish for chronic toxicity (NOEC/NOEL) -


> 100 mg/l for acute aquatic toxicity, or - > 10 mg/l for chronic aquatic toxicity


For each substances at or above 0,10% (w/w): Substances exhibiting a certain degree of aquatic toxicity are allowed in the hydraulic fluid up to a cumulative mass concentration indicated in the table hereafter:


Mode of preparation and tests description (WAF) In case of slightly water soluble substances or mixtures (<10 mg/l) the Water Accommodated Fraction (WAF) can be used in aquatic toxicity determination (OECD series of testing and assessment N°23, ASTM D 6081, Ecetox TR 26, ISO 5667-16, or equivalent method).


intentionally added mixtures and substances with their concentration in the final product.


Aquatic toxicity data Daphnia is preferred for crustacean aquatic toxicity. Algae is preferred for aquatic plants toxicity. If data have to be generated, tests will need to be performed are: -


-


Acute toxicity test on daphnia (e.g. OECD 202 – ISO 6341)


Acute toxicity test on algae (e.g. OECD 201 – ISO 8692)


Acute toxicity test on fish embryo (FET e.g. OECD 236)


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