Registering a chemical product

How to register a chemical product

To register a chemical product with OCNS you need to:

 

Fast-Track Options are available

The OCNS team operates under a commercial confidentiality remit. The information provided by individual suppliers will not be available to any other supplier.

Data requirements for OCNS registration

All substances included on a HOCNF must fully comply with the relevant requirements of REACH. Suppliers are advised to follow the REACH compliance flowchart shown in Figure 1 in the Guidance on completing the HOCNF before they commission relevant tests or complete the HOCNF with existing data.

All substances in the chemical product used in the offshore processing of petroleum need to be listed on the HOCNF form. The following requirements regarding each substance are mandatory:

inorganic substances do not require submission of biodegradation or bioaccumulation data for HMCS registration

Substances, which are on the latest REACH Annex IV list or on the list for substances which Considered to Pose Little or no Risk to the Environment (PLONOR) do not require the submission of Persistence, bioaccumulation and toxicity (PBT) data for HMCS registration.

Substances on REACH Annex V do not always fulfil the same criteria as substances on REACH Annex IV therefore the OCNS team have right to justify the need for PBT data submission for specific product registrations.

To increase the efficiency of the registration process if petroleum distillates, solvent naphtha, recognised UVCB and surface active substances that are covered by REACH are contained in the product, suppliers are requested to enter the REACH registration number and quote the REACH registered name of those substances. Additional information such as levels of substitution (ethoxylation/propoxylation) in moles must be provided as well as trade names.

Registration of the re-branded product

Re-brands of existing products are permitted under the OCNS, either as the same or a different name. Notification requires Letter of Access (LoA) from the company that owns the rights to the appropriate data on the HOCNF. (In rare cases this may be jointly owned).

In addition, a HOCNF from the company reuqesting the re-brand must complete the section 1.4 which describes their intended use and discharge of the product.

Letters of Access

A LoA is required when registering a product with one or more substances where any information is not fully known by the company submitting the HOCNF for registration, due to the information being proprietary to the Supplier (donor company)

Any supplementary supporting information should be forwarded to Cefas and cross-referenced to the trade name of the product so that Cefas can link the LoA to the relevant HOCNF. A declaration that the formulation has not been altered from that of the original product may also be required in case of whole product re-brand.

Cefas will only accept Letters of Access sent directly from the donor company and not the company registering the re-brand.

Cefas will accept 1 LoA per registration for 1 or more donor products to support that 1 registration.

An example letter of access has been provided on our downloads and useful links page.

Product submission for Recertification

Submission of data for a product to be recertified may be submitted up to six months prior to the expiry date. The recertification of the product will be dated from the expiry date, not the date of data submission.

Changes in the composition of a product when recertifying, that are outside the range quoted in the HOCNF Guidelines are likely to require the product to be renamed. This is to distinguish it from the original product when the operator discharge data is collated under the Environmental and Emissions Monitoring System (EEMS) and OSPAR recording systems.

Changes that only reflect the description of a substance on the HOCNF and which do not affect its actual composition in the registered product will not require the product to be renamed. However, such changes should be explained by the supplier submitting the HOCNF and Cefas may require supporting evidence.

Field trial registration

Field trial use of products not previously notified under OCNS or novel blends may be allowed after a consultation process with Cefas and the appropriate regulator.

Trials will usually relate to a specific site and last for a limited duration of six months. Information on the data requirements for both UK and Netherlands field trial registrations can be found in Appendix 5 of the Netherlands OCNS Protocol Part 1.

Following successful trials, classification for general use will require another submission of a full HOCNF data set.

Fast-Track

‘Fast-Track’ application requests for chemicals are available but can only be made by the operator via BEIS ( UK based) or SSM ( Netherlands based) depending on the geographic region that the chemical will be used in. All required data must be current and will only be processed if Cefas receives authorisation from the relevant regulator to ‘Fast Track’ the application