Submission procedure
7. How much time should I allow between making a submission and deploying a product offshore?
Cefas undertakes to certify a chemical within 8 weeks if we are in receipt of a full HOCNF dataset. Although we may turn round submissions in less time at certain times of the year, this should be seen as the exception rather than the norm. In practical terms 8 weeks should be allowed for any submission including those intended for field trials.
Applications can be submitted up to 6 months before expiry date. This will not affect the full 3-year term applied to the certification.
8. How do we report usage and discharge of drilling fluids to the EEMS database?
Water based mud systems (WBMs):
Water based muds (WBMs) containing <5% water-immiscible liquid should be reported as individual component products.
Organic phase mud systems:
Oil based muds (OBMs), synthetic drilling fluids (SMs) and emulsified water based muds containing >5% v/v water-immiscible liquid should be reported as made-up mud systems i.e. as shipped offshore. This should include any additional whole mud made up offshore. Additives and contingency chemicals put into the mud on the drilling rig should be reported separately.
9. How should I derive the dosage I submit on a HOCNF?
The product dosage you provide on the HOCNF supplied to Cefas must be the most realistic and common dosage for the use described and appropriate to the CHARM algorithm with which it will be assessed. The value may need to be derived in discussion with the operators who use the product. Dosage units will vary depending on product use, with the most commonly used being, parts per million (ppm), percentages (%), mg/kg water and pounds per barrel (ppb) (drilling fluid components only).
10. How many templates should I have for a single chemical?
Usually only one; but there could be two or three depending on the information you gave on the HOCNF. For example production chemicals used on both oil and gas platforms, and chemicals used both for drilling and completion/workover operations will have templates for each mode of use. If there is any doubt contact Cefas.
11. Why do I need to produce an HOCNF for all products that I use? Even, for example, those comprised wholly of substances included on the PLONOR list.
Although substances on the PLONOR list are sufficiently well known not to require ecotoxicity testing, the Regulator still requires information relating to the quantities of these products which are used and discharged to be reported on EEMS and PON 15s and the risks of large discharges of PLONORs to be discussed.
Industry may use certain products for different tasks and it is therefore important that each company notifies all their products separately on their own HOCNF document (even if this means that several companies all have 'sodium chloride' listed).
It is also possible that although a company may market a product under a 'generic' name there may be minor quantities of additives and preservatives present, which would never be reported if the product were not to be notified on a HOCNF. This also applies to generic commodity chemicals sourced from different mining areas and which may have different levels of contamination by materials such as heavy metals. Again such information would be documented by the Company specific HOCNF submission and allow the Regulator to act on this information if necessary.
12. I want to use a substance, which I think would be suitable as a PLONOR. How do I get it added to the PLONOR list?
You should discuss the substance with Cefas who will discuss it with DTI. If they both agree that your substance is suitable you should put together a HOCNF containing a data set that meets the criteria laid out the preamble to the PLONOR list (PDF, 190KB) (preferably in electronic form). References must be given for eco-toxicological data and a brief supporting justification should be added.
Cefas will review the data to ensure that the criteria for candidate PLONORs are met and that they are satisfied with the data presented. They will then pass their recommendation that the chemical is suitable for PLONOR status to the DTI and if DTI are content, Cefas will register the chemical as a Temporary OCNS Group E until 3 months after the next meeting of OIC (or the following meeting if the chemical is submitted within 20 weeks of the next meeting).
If OIC decide that the candidate substance is not suitable for addition to the PLONOR list, Cefas will notify the supplier, who will be required to submit a full HOCNF data set before a full 3-year certification is granted.
The full procedure is described in the attached document: Adding new PLONORs (PDF, 15 KB)
13. What data is required if I wish to re-brand another company's product?
Re-brands of existing products are permitted under the OCNS either as the same or a different name. Notification requires letters of authorisation from the company that owns the rights to the appropriate data on the HOCNF (in rare cases this may be jointly owned) and an HOCNF from the company requesting the re-brand detailing their intended use and discharge of the product. A declaration that the formulation has not been altered from that of the original product may also be required.
14. One of my products is a re-brand of an existing notified product, why has Cefas placed it in a different hazard band?
This is likely to be because your company's recommended dosage is different from your supplier's.
15. If I provide a letter of access for data on a chemical, which I manufacture and/or supply to be used in the certification of a re-brand or as a component in another company’s product, can that permission be time bound?
It is common for manufacturers or suppliers of products to require letters of access to enable read across of their product test data to be requested each time that the product is recertified. This permission can be bound to a specific period of time or, if left unspecified, Cefas will commonly request a new letter of access after three years. The arrangement may be changed or terminated at any time by a written request to Cefas from the owner of the original data.
16. I wish to notify a product but the manufacturer will not give me confidential formulation details, what can I do?
This common problem is easily solved by asking the manufacturer to provide the confidential details directly to Cefas referencing your submission. The third party has our assurance that the data will be treated as 'Commercial in Confidence' and will not be released to any other party, or used for any other purpose, without their specific written permission.
17. Can I have a product classified under the UK OCNS, but not have it listed on the List of Notified Chemicals?
This can be easily arranged and can be useful in situations where a company wishes to market a product that they do not supply directly for use offshore themselves, but which will be re-branded by other companies for use offshore. All that is required is an accompanying letter from the company concerned requesting that this action be taken.
18. What can I do if I notice an error in our Company’s entry on the List of Notified Chemicals or product templates?
Cefas maintains all the records of product submissions made to the OCNS on behalf of the DTI. This includes issuing the List of Notified Chemicals and product templates, which makes Cefas responsible for the accuracy of entries on them. It should be remembered that HOCNF documents are our only guide to the format of entry that is required on the list and we will reproduce both the syntax and spelling of the Company and Product names as shown on these documents. If changes to the text in the list or other documents are required, for any reason, Cefas can be contacted directly in writing (email, fax or letter) and we will alter the database if appropriate.
19. We understand that there is a new and more comprehensive list of product functions available, how do I arrange to update the function(s) assigned to my product(s)? What should I do?
The updated list of functions (from OIC 2003) is available from the OCNS downloads Page. If any changes need to be made to the functions assigned to your product(s), please advise the OCNS team in writing and they will be implemented as part of the routine product assessment process.
20. Do chemicals used in commissioning submarine oil and gas pipelines need to be notified to the OCNS?
The use and discharge of pipeline commissioning and hydro test chemicals are covered by the Offshore Chemical Regulations 2002 and suppliers of such chemicals are therefore required to submit an HOCNF as they would for any other offshore chemical. Pipeline operators are required to submit risk assessments discussing the use and discharge of pipeline chemicals on a PON 15C.
21. My formulation contains a hydrocarbon-based solvent, how should I describe this on a HOCNF?
In order to maintain consistent descriptions of hydrocarbon based solvents used in formulations registered with the UK OCNS, we have decided to adopt the names and descriptions listed in the CONCAWE Streamline Database Report 01/53 from http://www.concawe.be/Content/Default.asp?PageID=63 - 'Classification and Labelling (sic) of Petroleum Substances'.
Henceforth, all suppliers submitting HOCNFs for products containing hydrocarbon solvents should use the name and CAS number of the solvent from this database. e.g. Distillates (petroleum), hydrotreated light. CAS# 64742-47-8
It would also be helpful if you could quote the trade name under which you purchased the solvent and the name of the supplier. You may submit this information in the composition section of the HOCNF or in the associated 'Notes' section, or on a separate sheet alongside the HOCNF.
The CONCAWE streamline report is available as an Adobe Acrobat text file or as a Microsoft Access database.
22. Are products used for squeeze treatments and pipeline hydro-testing suitable for assessment of Hazard Quotient using the CHARM model?
The CHARM Implementation Network's (CIN) new algorithms for squeeze treatment and pipeline hydro-testing chemicals were added to the Cefas Database in June 2004. New templates reflecting these changes were issued for all existing chemicals.
23. How do I get Field Trial chemicals registered for use and for how long can I continue to use them?
Field trial use of products not previously notified under the Regulations or of novel blends of existing notified products may be allowed after a consultation process with the DTI and their environmental adviser (Cefas or FRS) as territorially appropriate. Prior to the trial it will also be necessary to register and obtain approval for the product (Cefas), and to request a relevant chemical permit or permit variation (DTI).
Field trial products submitted for registration will be certified within the agreed eight-week turnaround, as for non-trial products. More rapid processing may be possible if the use of the trial product addresses serious health and safety concerns or has immediate and significant environmental benefits. The evidence for this must be discussed with the DTI and, where appropriate, Cefas or FRS during the initial consultation.
In assessing products to be used in field trials, Cefas will require chemical suppliers to submit a HOCNF pro-forma with Parts 1 and 3 fully completed. The data that is submitted in Part 2 must be agreed with DTI and Cefas or FRS during the initial consultation. As an absolute minimum Cefas will require toxicity data from at least 1 appropriate toxicity test and biodegradation data for all knowingly added organic substances plus a detailed description of the use and fate of the product.
Wherever possible the proposed start date, location and duration of the field trial should be provided to accompany the HOCNF, together with an assessment of the environmental significance of any discharges that may result from the proposed trial. This information will be additionally required to support the application for a chemical permit or permit variation, and both the certification and the permit will be time-limited to reflect the agreed arrangements for the trial. If the start date and duration are not provided to accompany the HOCNF, the classification will be valid for three months. DTI should be contacted to obtain further information in relation to the initial consultation and chemical permitting processes.
24. Should a supplier notify laboratory reagents to OCNS or an operator report them to EEMs?
With effect from 20 April 2004 it is no longer necessary to register laboratory reagents under the OCNS. Previously there has been a requirement to register laboratory chemicals where the utilisation was in excess of 200 litres per year.
25. Several companies sell similar generically named products, why do they all have different HQs?
This is due to variations in the toxicity test, biodegradation and partitioning data and the dosages supplied by each company.
26. What constitutes a significant change to the product composition to warrant a name change?
Your attention is drawn to the contents of Cefas Guidelines to the HOCNF (PDF, 170 KB) and in particular the guidance provided for the completion of Section 1.6, page 4.
In the event of a subsequent change in composition or a change of concentration, e.g. as will occur with a dilution, then notification to the relevant authorities must be made on a fully completed HOCNF. If the change to the composition causes a variation greater than permitted on the original HOCNF, e.g. a new component is added then the product must be renamed. The details of the permitted variation in concentration, as initially reported on the HOCNF, are provided on page 3 of OSPAR HOCNF Guidelines for Suppliers (PDF, 35 KB).
