Substitution warning

The substitution of harmful chemicals is an important part of the Harmonised Mandatory Control Scheme (HMCS).  The UK is obliged to implement the policy to replace chemical substances identified as candidates for substitution. Products containing substitutable chemical substances are identified by the presence of a substitution warning placed on the product template.

An offshore chemical will be flagged with a substitution warning if:

is on the OSPAR List of Chemicals for Priority Action; 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 less than 1 mg/l;

or

• has a biodegradation of
  • less than 20% in OECD 306, Marine BODIS or any other accepted marine protocols; or
  • less than 20% in 28 days in freshwater (ready test);

or

• meets two of the following three criteria:
  • biodegradation: less than 60% in 28 days (OECD 306 or any other OSPAR-accepted marine protocol); or in the absence of valid results for such tests;
  • less than 60% (OECD 301B, 301C, 301D, 301F, Freshwater BODIS); or
  • less than 70% (OECD 301A, 301E);
  • bioaccumulation: BCF > 100 or log Pow ³ 3 and molecular weight <700;
  • toxicity: LC50 < 10mg/l or EC50 < 10mg/l; if toxicity values <10 mg/l are derived from limit tests to fish, actual fish LC50 data should be submitted;

A reliable value of Log Pow cannot be calculated for surfactants and therefore cannot be used to indicate whether a surfactant might bioaccumulate. OSPAR requires Regulatory Authorities to take a precautionary approach where data are ambiguous or missing. So substitution warnings will be applied to those surfactants that have a molecular weight of <700 and are either <60% or 70% biodegradable in 28 days (according to the test protocol) or have an EC50 or LC50 <10 mg l-1, unless Cefas is satisfied that other evidence submitted by the supplier indicates that the substance should not bioaccumulate.

• Assessing Bioaccumulation of Surfactants (PDF, 107 KB)

During 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 including candidates for substitution. Operators are required to provide a robust defence for the continued use of products that have a high RQ or contain candidates for substitution.

Chemical suppliers must consider the advice they provide to operators that justifies continued use of any product containing candidates for substitution. In addition suppliers should consider a managed approach to the replacement of any undesirable components, leading to the reformulation and re-certification of products.

Cefas are happy to explain any substitution warning assigned to a product, and to discuss any approach you may be considering in addressing these issues, OCNS Contacts.

It should also be noted that operators will be encouraged to select products that do not have a substitution warning and therefore a supplier may wish to seek alternatives at the product development stage. However, there may be good technical reasons why a particular substance cannot immediately be substituted. 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.

United Kingdom National Plan for the Phase-out of Substances Identified as Candidates for Substitution

Having considered potential strategies for reducing the discharge of substitutable substances in line with OSPAR Recommendation 2006/3, the UK has decided to base its National Plan for the prioritisation of phase-out of substances identified as candidates for substitution on the following criteria:

• perceived difficulty of phase-out;
• securing the replacement of candidates for substitution in preference to eliminating operational discharges to the marine environment.
• the persistence, bioaccumulation and toxicological (PBT) properties of the chemicals;

The UK National Plan also incorporates justification of continued use and/or discharge as an additional element: For those substances where replacement and/or eliminating discharges to the marine environment is not currently feasible, offshore operators or their chemical suppliers will annually be required to:

• confirm the efforts made to phase out the use and/or discharge of the candidate for substitution;
• confirm the nature and timing of planned research and development studies or trials to supplement those efforts;
• confirm whether any measures have been taken to reduce the use and/or discharge of the candidate for substitution; and
• confirm the technical and/or safety issues that make it necessary to continue to use and/or discharge the candidate for substitution.

The prioritisation based on PBT properties will involve all candidates for substitution being assigned a priority level, based on these properties. DECC intends to include the UK National Plan level on a newly designed Cefas template in due course. However, in the interim, chemical suppliers will be informed of the UK National plan level of their products and will be required to communicate this information to downstream users of the products. Criteria for assigning levels and interim target dates are shown in Table 1.

Table 1: UK National plan level criteria and interim target dates.

Highly persistent

Biodegradation less than 20% in OECD 306, 301 or 302

Moderately persistent

Biodegradation greater or equal to 20% but less than 60% in OECD 306 or, marine BODIS or, OECD 301 (B, C, D, F) or, freshwater BODIS; or less than 70% in the OECD 301 (A, E) or equivalent internationally recognised test protocol.

Bioaccumulating

1. LogP_ow greater or equal to 3, or
2. surfactant (as defined by OSPAR)

unless

1. molecular weight greater than 700 g/mol, or
2. bioconcentration factor is less than 100, or
3. weight of evidence indicates substance does not bioaccumulate            

Toxic

Lowest LC50/EC50 <10mg/l 

Inclusion of UK National Plan Levels on Cefas templates. 

To facilitate the implementation of UK National Plan for the Phase-out of Substances Identified as Substitution Candidates, DECC has decided to include the product UK Nation Plan Level (UK NPL) on a newly redesigned Cefas template. The product UK NPL will be the lowest substance UK NPL value (1 to 4) for all substitutable components in a product, regardless of their relative proportions.

The advantages of this approach are:

• The system will be transparent and simple for regulators, chemical suppliers, operators and their subcontractors to use
• The data that have led to the generation of the products UK NPL will remain the confidential property of the chemical supplier or their third party supplier
• Chemical suppliers will still control who they allow to access their templates and therefore the UK NPL for a product
• Operators using a product will immediately be able to determine the UK NP date for a product whilst reviewing the Cefas template as part of their preparation of PON 15s and ES
• Operators and their suppliers will easily be able to develop a strategy under the UK NP as to whether to justify a products continued use past its UK NP date, phase out the use of the product or substitute the product for one with a better environmental profile

There is no intention to publish UK NPL for products on the World Wide Web nor will the individual substance UK NPL values be made publicly available.

• Substitution FAQs