Commission Decision (EU) 2018/1702Show full title

CRITERION 2 — ADDITIONAL AQUATIC TOXICITY REQUIREMENTS U.K.

The applicant shall demonstrate compliance by meeting the requirements of either criterion 2.1 or 2.2.

2.1. Requirement for the lubricant and its main components U.K.

The critical concentration for the aquatic toxicity for both the freshly prepared lubricant and for each main component shall not be lower than the values specified in Table 2.

Main component means any substance accounting for more than 5 % by weight of the lubricant.

Table 2

Aquatic toxicity values for both freshly prepared lubricant and for each main component

		ALL	PLL	TLL
Aquatic toxicity for the freshly prepared lubricant	Critical concentration for acute aquatic toxicity OR	> 100 mg/l	> 1 000 mg/l	> 1 000 mg/l
	Chronic aquatic toxicity	> 10 mg/l	> 100 mg/l	> 100 mg/l
Aquatic toxicity for each main component	Critical concentration for acute aquatic toxicity OR	> 100 mg/l
	Chronic aquatic toxicity	> 10 mg/l

Available acute aquatic toxicity test data for each main component shall be provided on each of the following two trophic levels:

• crustacean (daphnia preferred),

• aquatic plants (algae preferred).

In case acute aquatic toxicity test data is missing in one or both trophic levels, available test data on chronic aquatic toxicity for both the crustacean (daphnia preferred) and fish trophic level shall be accepted.

QSARs could be used to fill data gaps for chronic toxicity or for acute toxicity in only one of the relevant trophic levels.

In case the aforementioned test data is not available for each main component, a test shall be performed to generate data for acute toxicity in the missing trophic level/s (i.e. crustacean and/or aquatic plants).

Available acute aquatic toxicity test data for the lubricant shall be provided on each of the following three trophic levels:

• crustacean (daphnia preferred),

• aquatic plants (algae preferred),

• fish.

In case acute aquatic toxicity test data for the applied lubricant is missing for any of the mentioned trophic levels available test data on chronic aquatic toxicity shall be accepted for the missing trophic level/s.

In case the above data is not available for the applied lubricant, a test shall be performed to generate data on acute aquatic toxicity for the missing trophic level/s.

2.2. Requirement for each intentionally added or formed substances at or above 0,10 % weight by weight in the final product U.K.

Substances exhibiting a certain degree of aquatic toxicity are allowed up to a cumulative mass concentration indicated in Table 3.

Table 3

Cumulative mass percentage (% w/w) limits for substances present in the product with respect to their aquatic toxicity

a M-factors for highly toxic components of mixtures shall be applied in accordance with Article 10 of Regulation (EC) No 1272/2008 as described in Section 4.1.3.5.5.5 of Annex I to that Regulation.
	Cumulative mass percentage (% weight by weight in the final product)
	ALL	PLL	TLL
Acute aquatic toxicity > 100 mg/l orChronic aquatic toxicity > 10 mg/l	Not limited
Acute aquatic toxicity > 10 to ≤ 100 mg/l or1 mg/l < Chronic aquatic toxicity ≤ 10 mg/l	≤ 10 (≤ 20 for ALL greases)	≤ 10 (≤ 15 for PLL greases)	≤ 2 (≤ 10 for TLL greases)
Acute aquatic toxicity > 1 to ≤ 10 mg/l or0,1 mg/l < Chronic aquatic toxicity ≤ 1 mg/l	≤ 2,5 (≤ 1 for ALL greases)	≤ 0,6	≤ 0,4
Acute aquatic toxicity≤ 1 mg/l orChronic aquatic toxicity ≤ 0,1 mg/l	≤ 0,1/Ma	≤ 0,1/Ma	≤ 0,1/Ma

Available chronic aquatic toxicity test data for each substance (each intentionally added or formed substances at or above 0,10 % weight by weight in the final product) shall be provided for each of the following two trophic levels:

• crustacean (daphnia preferred), and

• fish

In case chronic aquatic toxicity test data is missing in one or both trophic levels, available data on acute aquatic toxicity for both trophic levels, crustacean (daphnia preferred) and aquatic plants (algae preferred) shall be accepted.

QSARs could be used to fill data gaps for chronic toxicity or for acute toxicity in only one of the relevant trophic levels.

In case the above data is not available for each substance, a test shall be performed to generate data for acute toxicity in the missing trophic level/s (i.e. crustacean and/or aquatic plants).

Assessment and verification applicable to criteria 2.1 and 2.2 U.K.

In case of self-assessment by the applicant, for each substance, main component or for the lubricant, the applicant shall provide test reports or literature data including the references demonstrating compliance with the requirements set in sub-criterion 2.1 or 2.2.

For each substance or main component where the assessment is based on a valid letter of compliance (LoC), a copy of the letter shall be provided. For each substance or main component selected from the Lubricant Substance Classification list (LuSC-list) the assessment can be based on the information reported in said list and no documents need to be submitted.

Either marine or freshwater toxicity data are accepted.

Acute aquatic toxicity data (available or generated for the application) shall originate from tests carried out according to:

• ISO 10253 or ISO 8692 or OECD Test Guideline 201 or Part C.3 of the Annex to Commission Regulation (EC) No 440/2008(1) for algae,

• ISO 6341 or OECD Test Guideline 202 or Part C.2 of the Annex to Regulation (EC) No 440/2008 for daphnia,

• ISO 7346 or OECD Test Guideline 203 or Part C.1 of the Annex to Regulation (EC) No 440/2008 for fish (only applies to available existing data),

• fish embryo toxicity (FET) (non-animal alternative) test according to OECD Test Guideline 236 or part C.49 of the Annex to Regulation (EC) No 440/2008 for fish (only applies when a test needs to be performed for the application).

Only acute aquatic toxicity (72 or 96 hr) ErC₅₀ for algae, (48hr) EC₅₀ for daphnia and (96hr) LC₅₀ for fish are accepted.

Chronic aquatic toxicity data (available) shall originate from tests carried out according to:

• ISO 10253 or ISO 8692 or OECD Test Guideline 201 or Part C.3 of the Annex to Regulation (EC) No 440/2008 for algae,

• Part C.20 of the Annex to Regulation (EC) No 440/2008 or OECD Test Guideline 211 for daphnia,

• OECD Test Guideline 215 or Part C.14 of the Annex to Regulation (EC) No 440/2008 or ISO 12890 or OECD Test Guideline 212 or part C.15 of the Annex to Regulation (EC) No 440/2008 or OECD Test Guideline 210 for fish.

Only chronic toxicity data in the form of No Observed Effect Concentration (NOEC) data shall be accepted.

When QSARs are used to fill data gaps, the applicant shall provide the prediction generated for the target chemical. Results of (Q)SARs shall only be accepted if documentation on the validity and applicability domain of the applied model is provided by the applicant.

In the case of slightly soluble substances or mixtures (< 10 mg/l) the method of the water-accommodated fraction (WAF) can be used in the aquatic toxicity determination. The established loading level referred to as LL50 and related to the lethal loading or the EL50 related to the effective loading for acute aquatic toxicity and NOELR related to the no observable effect loading rate for chronic aquatic toxicity may be used directly in the classification criteria. The preparation of a water-accommodated fraction shall follow the recommendations set out according to one of the following guidelines: Appendix C to ECETOC Technical Report No 26 (1996), OECD 2002 Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures (OECD Series on Testing and Assessment, No 23), ISO 5667-16 Water quality — Sampling — Part 16 (Guidance on biotesting of samples), ASTM D6081-98 (Standard practice for Aquatic Toxicity Testing for Lubricants: Sample Preparation and Results Interpretation) or equivalent methods. In addition, demonstration of the absence of toxicity for a substance at its limit of water solubility shall be deemed to have met the requirements of this criterion.

The following substances are exempted from requirements 2.1 and 2.2:

• any substance which is unlikely to cross biological membranes MM > 800 g/mol and with a molecular diameter > 1,5 nm (> 15 Å), or

• any substance which is a polymer and whose molecular weight fraction below 1 000 g/mol is less than 1 %, or

• any substance which is highly insoluble in water (water solubility < 10 μg/l)

The water solubility of substances shall be determined where appropriate according to OECD Test Guideline 105 or Part A.6 of the Annex to Regulation (EC) No 440/2008 or equivalent test methods.

A polymer molecular weight fraction below 1 000 g/mol shall be determined according to Part A.19 of the Annex to Regulation (EC) No 440/2008 or OECD Test Guideline 119 or equivalent test methods.

(1)

Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 142, 31.5.2008, p. 1).