Warning notices

Substitution is an important component of the Harmonised Mandatory Control Scheme (HMCS), and the UK is obliged to implement a strategy to replace chemicals that have been identified as candidates for substitution, or contain components that have been identified as candidates for substitution. 

An offshore chemical should be substituted if it:

• is on the OSPAR List of chemicals for priority action, or
• on the List of chemicals of possible concern, or
• in REACH (EC 1907/2006) Annex XIV or XVII
• is considered by the authority, to which the application has been made, to be of equivalent concern for the marine environment, or
• is inorganic and has a LC₅₀/EC₅₀ <1 mg/l, or
• has a biodegradation of:
  • <20% in 28 days  (OECD 306, marine BODIS or any other acceptable marine protocols), or
  • <20% in 28 days (freshwater data OECD 301 and 310), or
  • if half-life values >60 and 180 days from simulation tests in marine water and sediment respectively (e.g. OECD 308, 309)
• or meets two of the following three criteria:
  • biodegradation:
    • <60% in 28 days in OECD 306, marine BODIS or any other acceptable marine protocol, or in the absence of valid results for such tests (<60% in 28 days (OECD 301B, 301C, 301D, 301F, 310, freshwater BODIS), or
    • <70% in 28 days (OECD 301A, 301E), or
  • bioaccumulation: 
    • BCF >100 or Log P_ow ≥3 and molecular weight <700, or
    • if the conclusion of a weight-of-evidence expert judgement under Appendix 3 of OSPAR Agreement 2008-5 is negative, or
  • toxicity:
    • LC₅₀ <10mg/l or EC₅₀ <10mg/l.

As part of the risk-assessment process operators are required to consider the selection of products, both in terms of the magnitude of their Risk Quotient (RQ) and the presence of hazardous substances or candidates for substitution. Operators will be required to provide a robust defence for the continued use of products that have a high RQ or contain candidates for substitution.

Chemical suppliers will wish to consider the advice they provide to operators that justifies continued use of any product containing candidates for substitution. In addition, they should consider a managed approach to the replacement of any undesirable components, leading to the reformulation and re-certification of the product. Cefas is happy to explain any substitution warning that has been assigned to a product, and to discuss any approach that suppliers/operators may be considering to address these issues.

It should also be noted that operators will be encouraged to select products that do not contain a substitution warning. Therefore, a supplier may wish to seek alternatives when at the product-development stage. However there may be good technical reasons why a particular substance cannot immediately be substituted and the supplier will wish to highlight these to operators so that they can include this information in their justification for continued use of the product.

Whenever the formulation/composition of a product is changed beyond the limits permitted under the regulations, the new formulation must receive a new name. This is non-negotiable.

The UK is obliged to regularly report to OSPAR the total quantities of chemicals that are used and discharged offshore. In addition, Regulators are obliged to closely monitor the use of those chemicals identified by Annex A of the Paris Convention for the protection of the Marine Environment of the North-East Atlantic (1992). For this reason warnings are added to products, which are not wholly comprised of the substances in question. Government and industry can therefore readily identify those products that may contain these materials and report these to OSPAR via use of the EEMS database.

It therefore follows that when selecting products for use offshore, operators should approach their suppliers for more detailed information on the component in question. This allows consideration of the risks that might be posed by the use and especially the discharge of such materials. In addition to Annex A substances, regulatory authorities are also obliged to flag endocrine-disrupting substances, even if present at similarly low levels.

Cefas uses the test values on individual HOCNFs when ranking chemicals but we adopt a "global" approach for substitution, to avoid the possibility of marking a substance for substitution on one supplier's data and not on another.

Please ask the OCNS team to confirm which substance the warning applies to. If your test data could result in the removal of the warning, please submit a copy of the relevant test report to Cefas. We will remove the substitution warning from your product and all others containing the same substance if we regard the data as valid.

For more detail on the prioritisation of substances for substitution please see the UK substitution strategy (PDF, 101 KB).

Paragraph 44 of the OECD protocol says: "Owing to the relatively high test concentrations as compared with most natural systems, and consequently an unfavourable ratio between the concentrations of test substance and other carbon sources, the method is to be regarded as a preliminary test which can be used to indicate whether or not a substance is easily biodegradable. Accordingly, a low result does not necessarily mean that the test substance is not biodegradable in marine environments, but indicates that more work will be necessary in order for this to be established."

Chemical suppliers are therefore encouraged to submit additional data to prove that a substance is or is not biodegradable. For substances shown to be <60% or <70% biodegradable (depending on the test endpoint) in an OECD 306, this could be an extended OECD 306 or an OECD 301 ready test. If the OECD 306 test showed the substance to be <20% biodegradable, or if a ready aerobic biodegradation test has not been performed, it will be assumed that the substance is persistent in aerobic conditions unless a simulation test (e.g. OECD 308, OECD 309) is performed, which indicates the opposite.

To be acceptable for registration of offshore chemicals, all Quantitative Structure Activity Relationship (QSAR) calculations must be fully validated. A part of the validation exercise for an acceptable QSAR assessment must include demonstration that the method is directly applicable to the substance concerned.

Validation must either:

• demonstrate that the training-set on which the QSAR is based is directly relevant to the substance for which it is being used to predict a parameter

or

• demonstrate that the calculation method is able to calculate the parameter of interest for members of a homologous series of substances (structurally related to the substance of interest), for which experimentally determined data may be found in the literature. The experimentally determined literature values need not come from studies conducted to Good Laboratory Practice levels, but in such cases Cefas will make a quality assessment and take a weight-of-evidence approach during the evaluation of these data.

The test for a surfactant will only be required when there is disagreement between a supplier and Cefas as to whether a substance is a surfactant. If a substance is not declared as a surfactant on the HOCNF, but as a result of literature surveys and expert knowledge Cefas believe that a substance is a surfactant, we will communicate that view and reasoning to the supplier. If the supplier is unwilling to accept our view, and cannot present scientific evidence to convince us to change their evaluation, a surfactant test will be required.

Weight-of-evidence approach for bioaccumulation assessment of surfactants

Any supplier intending to submit a weight-of-evidence-based evaluation of a substance in line with Annex 1 of the guidance to the HOCNF should contact Cefas to discuss the suitability of their approach before starting work. General guidance for the type of approach that may be acceptable are outlined in the following references:

de Wolf, W., Comber, M., Douben, P., Gimeno, S., Holt, M., et al. (2007). Animal Use Replacement, Reduction, and Refinement: Development of an Integrated Testing Strategy for Bioconcentration of Chemicals in Fish. Integrated Environmental Assessment and Management: Vol. 3, No. 1, pp. 3-17.

Millais, A.J., Rycroft, R.J., Tolhurst, M.A., Sheahan, D.A. (2007). Bioconcentration: Comparison of methods for assessing potential hazards of offshore chemicals. Chemistry in the Oil Industry: X, 5-7 November 2007.