Warning notices

1. My product has a substitution warning applied to it. What does this mean and what action should I take?

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 listed in Annex 2 of the OSPAR Strategy with regard to Hazardous Substances; or
Is considered by the authority, to which the application has been made, to be of equivalent concern for the marine environment as substances covered by the previous sub-paragraph; or
Is inorganic and has a LC50 or EC50 < 1 mg/l; or
Has a biodegradation < 20% during 28 days; or meets two of the following three criteria:
- Biodegradation in 28 days < 70% (OECD 301A, 301E) or < 60% (OECD 301B, 301C, 301F, 306);
- Either, bioaccumulation log Pow > 3 and molecular weight of the substance is < 600, or BCF > 100
- Toxicity LC50 / EC50 < 10 mg/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 you provide to operators that justifies continued use of any product containing candidates for substitution. In addition, you should consider a managed approach to the replacement of any undesirable components, leading to the reformulation and re-certification of your product. We would be happy to explain any substitution warning that has been assigned to a product, and to discuss any approach that you 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 and 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.

2. Why are warnings assigned to the whole product, when the component to which the warning applies is only a small fraction of the total composition?

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 to allow 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.

3. My product carries a substitution warning, yet none of my company's data on the components appear to justify the warning?

Whereas Cefas use the test values on individual HOCNFs when ranking chemicals, 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 and 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.

4. My product is likely to attract a substitution warning on account of a poor result in an OECD 306 biodegradation test. What should I do?

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 end point) 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, we would recommend an appropriate inherent test.

5. What has happened to the taint warning formerly displayed on a template?

OIC 2005 agreed that the application of taint warnings to offshore chemicals should be addressed by individual Contracting Parties rather than being a mandatory requirement as at present.

OIC therefore removed Paragraph 46 of the OSPAR Guidelines for Completing the Harmonised Offshore Chemical Notification Format (HOCNF) (reference number 2003-1) and section 2.3 of Appendix 1 to the OSPAR Recommendation 2000/5 on a Harmonised Offshore Chemical Notification Format (HOCNF), both of which referred to the application of taint warnings.

DTI have discussed the relevance of taint with their advisors at Cefas and FRS and have agreed that it is most unlikely that any routine discharge of an offshore chemical would lead to the tainting of seafood. They therefore asked Cefas to remove taint warnings from product templates and the list of notified chemicals. This was carried out on the 24 May 2005.

Product taint warnings will remain on the OCNS database to enable Cefas to advise the relevant authorities in the event of a chemical spill and the OSPAR list of substances likely to cause taint will continue to be available as a download from this website for information purposes.

6. Are physicochemical or toxicity data that are calculated using Quantitative Structure Activity Relationships (QSAR) acceptable for substance registration?

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.

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 GLP, but in such cases Cefas will make a quality assessment and take weight-of-evidence approach during the evaluation of these data.