Guidance

Approval process of oil spill treatment products in the UK

Updated 13 December 2018

1. Dispersants

Companies planning to market a dispersant product for use in UK waters should first apply to the MMO to have it approved. The product must be tested for its efficacy and for its toxicity. The MMO must also approve the proposed product’s labelling and ensure that it provides users with appropriate information including how and when the product can be used.

Approval is required not only for new products but also for the rebranding of an existing product under a new name. The approval must be renewed after five years (or less where specified), and the approval holder must ensure that the MMO is notified of any change in the company’s name, address or the composition of the product.

The efficacy and toxicity tests can either be carried out within MMO commissioned laboratories, or by independent laboratories selected by the applicant following standard test protocols supplied by the MMO. Companies may choose an independent laboratory with recognised accreditation for either the toxicity test or the efficacy test; or both.

The fees payable to the MMO will be dependent on the laboratory that carries out the testing.

Where a company uses an independent laboratory, there will be no testing fee but a charge will be made for the evaluation of the test results to ensure that they conform to an appropriate standard of scientific quality and adherence to the standard protocols.

2. Other oil spill treatment products

The MMO is also responsible for the approval of other oil spill treatment products intended for use in UK waters, these include; sorbents, bioremediation products and degreasers. The approval process for these products is broadly similar to that for dispersants, although the test protocols (and consequently the fees charged) may differ. Sorbents, for example, do not have to undergo an efficacy test.

Bioremediation products are subject to two further toxicity tests, and it will also be necessary to obtain microbiological hazard data. If the Bioremediation product contains a bacterial component you may need to apply for a wildlife licence.

3. Testing

There is a suite of tests required dependant on the type of product. These tests are designed to test a product for efficacy and toxicity.

Type of test	Dispersant (inshore* and offshore*)	Dispersant (offshore only)	Sorbent	Bioremediation product	Degreaser
Cefas protocol for efficacy or WSL LR 448	Yes	Yes	No	No	No
Flask test	No	No	No	Yes	No
Microcosm test	No	No	No	Yes	No
Rocky shore test	Yes	No	Yes	Yes	Yes
Sea test	No	No	No	Yes	no
Agitation toxicity test 2	No	No	No	Yes	No
Wildlife licence	No	No	No	Yes (if contains bacteria)	No

• Inshore includes: Sea, beach and rocky shore
• Offshore include: Sea only. Offshore products should not be used on any beach or rocky shore.

3.1 Efficacy testing

There are 2 types of efficacy testing accepted in the UK. Products submitted to the MMO after 1 March 2017 will be tested for conformity with the Cefas protocol for efficacy testing.

The efficacy test aims to assess the proportion of the total volume of treated oil that is dispersed into the water column. This includes aspects of appearance, dynamic viscosity, flash point, cloud point, miscibility and efficacy.

Products can also be tested to the specifications outlined in appendix A of WSL Report LR448.

3.2 Toxicity testing

There are 2 toxicity tests. The first test, the sea test, is carried out using the brown shrimp (Crangon crangon). This test compares the relative toxicity of an oil-product mix to that of the oil alone.

The second test is called the rocky shore test and is carried out using the common limpet (Patella vulgata). This test compares the toxicity of the product alone to that of the standard test oil.

All new products must pass toxicity testing relevant to where they can be used.

4. Fees

4.1 Approval for renewal or rebrands

All renewals or rebrands will be charged a fee of £1,100.

4.2 Dispersants and Sorbents testing

These prices are not inclusive of VAT.

Product	Performance and efficacy test (£)	Toxicity assessment: Sea test (£)	Toxicity assessment: Rocky Shore test (£)	Total fee payable (£)
Dispersant type 1	3,150	7,631	6,909	18,085
Dispersant type 2	3,150	7,631	6,909	18,085
Dispersant type 3	3,150	7,631	6,909	18,085
Dispersant type 2/3	3,150	7,631	6,909	18,085
Evaluation of test data produced by an independent laboratory	1,100	1,100		2,200

4.3 Bioremediation products

These prices are not inclusive of VAT.

	Performance and efficacy test (£)	Toxicity assessment: Sea test (£)	Toxicity assessment: Rocky Shore test (£)	Toxicity assessment: Extended sea test (£)	Total fee payable (£)
Bioremediation test	4,310	7,631	6,909	7,631	26,481
Evaluation of test data produced by an independent laboratory	1,100	1,100			2,200

Information on how to make a payment.

5. Labelling

The product label must be agreed by the MMO before the product can be approved. The label must contain the following information:

1. Product name.
2. Name, address and daytime or silent hour’s telephone number of manufacturer or importer or rebrander.
3. List of ingredients.
4. Oil treatment product (dispersant type, sorbent, bioremediant or other).
5. A warning against mixing the product with any other products.
6. Date of manufacture, batch number and expiry date (subject to extension).
7. Recommended storage instructions.
8. Risk symbol and description.
9. Usage instructions including a statement that details that the product should not be used without the approval of the licensing authority.
10. Basic safety instructions or caution and any appropriate chemical hazard signs.

The label should also meet the requirements of the Classification, Labelling and Packaging (CLP) Regulations.

Information on the requirement is held on the European Chemical Agency website.

6. Getting an oil spill treatment product approved: a step-by-step guide

6.1 Step 1

Obtain the relevant application form.

6.2 Step 2

Send the completed application form to Dispersants@marinemanagement.org.uk. You will also need to provide evidence in support of your application. The amount of supporting information required varies:

• renewals of existing approvals and the rebranding of an approved product under a new name will be considered on the basis of an understanding (or confirmation from the manufacturer) that the composition of the product is totally unchanged.

• products which have not previously been approved for use in the UK will need to undergo the relevant tests. In all cases the application must be accompanied by an example of the proposed label.

6.3 Step 3

If you choose to have the tests carried out by the MMO’s commissioned laboratory Cefas, then please send a sample of the product directly to Cefas. The size of the sample will depend on the types of tests required. Full details and the address are given on the application form.

If you have tested the product via an independent laboratory, send the test results to the MMO with the application form and the label. The MMO will arrange to evaluate the test data to ensure that it conforms to the standard test protocols.

6.4 Step 4

Await feedback on test results to confirm whether product can be approved or not approval.

We aim to conduct all tests within 12 weeks of receiving payment, a correctly completed application form, data sheet and label. The product may be marketed for use in UK waters as soon as the MMO issues the formal approval notice. The official approved products list which is published on Gov.uk website will be updated with the new product being listed on it, or a new expiry date for a renewal.

6.5 Step 5

All dispersants stocks, other than products kept in the manufacturer’s original, unopened and undamaged package, must be tested for efficacy within five years from the date of manufacture and on a five-yearly cycle thereafter. All stocks held in the original, sealed manufacturer’s packaging must be tested for efficacy within ten years of the date of manufacture and thereafter at no longer than five-yearly intervals.

Stored products are tested for efficacy using the same standard laboratory-based procedure for dispersant approval as described in Cefas Protocol for Efficacy or Annex 1 to Appendix A WSL Report LR448. Some loss of efficacy is permissible. Therefore, the pass rate is set at 75% of the original minimum standard of efficacy, for example, for a type 3 dispersant the retest pass level will be 45%. Stocks which fail to achieve this pass level should be disposed of in accordance with waste regulations.

7. Retesting for efficacy

All dispersants stocks, other than products kept in the manufacturer’s original, unopened and undamaged package, must be tested for efficacy within five years from the date of manufacture and on a five-yearly cycle thereafter. All stocks held in the original, sealed manufacturer’s packaging must be tested for efficacy within ten years of the date of manufacture and thereafter at no longer than five-yearly intervals.

Stored products are tested for efficacy using the same standard laboratory-based procedure for dispersant approval as described in Cefas Protocol for Efficacy or Annex 1 to Appendix A WSL Report LR448. Some loss of efficacy is permissible. Therefore, the pass rate is set at 75% of the original minimum standard of efficacy, for example, for a type 3 dispersant the retest pass level will be 45%. Stocks which fail to achieve this pass level should be disposed of in accordance with waste regulations.