The OSPAR Commission's (OSPAR) Harmonized Offshore Chemical Notification Format (HOCNF) is of paramount importance for a wide range of personnel, including chemical manufacturers and product manufacturers whose products are used on an offshore oil platform. Despite its significance, many in the U.S. are largely unaware of its role in the petrochemical community. We describe the program generally below focusing on the interrelations with other chemical programs, including the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.

Background

The Convention for the Protection of the Marine Environment of the North-East Atlantic (OSPAR Convention) entered into force in 1998 and is the current legislative instrument regulating international cooperation on environmental protection in the North-East Atlantic. More information is available online.

All work carried out under the OSPAR Convention is managed by OSPAR, comprised of representatives of the governments of 15 signatory nations and representatives of the European Commission (EC) and European Union (EU). The OSPAR Maritime Area (North Sea and North-East Atlantic) is comprised of five regions based on the characteristics of their ecosystems. Regions I through V vary significantly in ecosystems. For example, Region II, the Greater North Sea, is one of the busiest maritime areas and is surrounded by densely populated, highly industrialized countries. Whereas Region III, the Celtic Seas region, contains wide variations in coastal topography, from fjordic sea lochs to sand dunes, bays, and numerous sandy beaches.

The HOCNF seeks to harmonize measures and criteria used by signatory states to the OSPAR Convention with the primary objective of preventing unacceptable damage to the marine environment from the use, discharge, and accidental loss of exploration and production chemicals within the OSPAR Maritime Area.

HOCNF

Chemical suppliers are required to provide national authorities with data and information about chemicals used and discharged offshore according to the HOCNF. Competent national authorities carry out pre-screening and take regulatory action, such as issuing discharge permits, based on this information. Chemical suppliers should follow the OSPAR Guidelines for Toxicity Testing of Substances and Preparations Used and Discharged Offshore, OSPAR's Protocols on Methods for the Testing of Chemicals Used in the Offshore Oil Industry, and OSPAR's Guidelines for Completing the HOCNF.

HOCNF and REACH

A very important correlation exists between the HOCNF and REACH. All substances notified according to the HOCNF must fully comply with the relevant REACH requirements for the substance. Substances that are not registered, pre-registered, or exempt under any of the REACH Annexes are unlikely to be successful under the HOCNF. Annexes IV, V, XIV, and XVII are of critical importance to the HOCNF application process and are discussed below in "product preliminary review." More information is available online.

HOCNF Application Process

The HOCNF application process can be analyzed efficiently when divided into four distinct stages:

• Product Preliminary Review;
• Data Gap Analysis and HOCNF Application;
• Competent Authority Pre-screening; and
• Recertification.

Product Preliminary Review

Companies are strongly advised to undertake an in-house preliminary review process before starting an HOCNF application. It is critically important to understand thoroughly all of the tasks that must be performed, along with timeframe, cost, and expected outcome. Although companies apply for use of a certain product, the assessment process is substance-based and therefore each component will be assessed and needs to be tested separately.

All components of the product must be checked for REACH registration status and/or applicability of other legislation (e.g., Biocidal Product Regulation (BPR)). It is highly recommended that the following REACH Annexes be consulted during this initial product review:

• Annex IV;
• Annex V;
• Annex XIV; and
• Annex XVII.

Applicants must also be aware of the implications of some of the specific elements that are unique to OSPAR, the OSPAR Pose Little or No Risk (PLONOR) list, the OSPAR List of Chemicals for Priority Action (LCPA), and the OSPAR List of Substances of Possible Concern (LSPC). Each list affects how the Competent Authority views the product. Additional detail is provided in the Competent Authority Pre-screening section below. More information is available online.

Data Gap Analysis and HOCNF Application

The application process for the HOCNF is described in detail in the Guidance Document on the OSPAR website. The elements have a heavy focus on marine environments and compositional details. It is important to review each component of your product against the Guidance Document to ensure the application is complete.

There are four key elements to the application: general information, ecotoxicological data, confirmation statement, and supporting documentation. The general information and ecotoxicological data portions are the most strenuous and include specifics on chemical composition, use and discharge, aquatic toxicity, biodegradability, and bioaccumulation potential.

A keen understanding of the main goal of the OSPAR HOCNF is required when completing the elements of this application as the data are marine driven, use-, and component-specific. It is encouraged when dealing with products that do not typically perform well in ecotoxicity testing (e.g., poorly water soluble, inorganic, polymeric, or surfactants) to consult the guidances, as well as the Competent Authority for assistance in completing the application elements.

Competent Authority Pre-screening

Upon receipt of the application, the Competent Authority identifies components, if any, that should be substituted and ultimately phased out. The Competent Authorities check whether any of the substances involved are on the lists of substances of concern, both under REACH and OSPAR. While listing on Annex IV or V of REACH or the PLONOR list may lead to a significantly reduced application process; substances on Annex XIV or XVII of REACH or LCPA or LSPC of OSPAR might receive a substitution warning, and require a more intense review process by the Competent Authority, including submission of additional data elements.

The Competent Authority may then go on to conduct a more detailed assessment using the Chemical Hazard Assessment and Risk Management (CHARM) model or may proceed to a decision process. The CHARM model is a tool used to support environmental hazard assessment, but is not utilized by all of the Competent Authorities.

Once the Competent Authority assessment is complete using relevant measures and models, the applicants can receive one of the following decisions:

• Permission to Proceed;
• Substitution Warning;
• Temporary Permission; or
• Refusal.

It is important to note that substitution warnings do not result in an immediate substitution and are not equal to a refusal. Substitution warnings can result, however, in commercially negative implications for the substance from a marketing perspective.

Recertification

Upon completion of the HOCNF application process, companies are required to submit a certification statement. Companies also have obligations that extend beyond initial approval of the product. HOCNF application submitters are required to notify Competent Authorities immediately in case of:

• Changes in formulation regardless of amount;
• Changes in name, coding, or numbers; and
• Changes that are not of substantial relevance to chemistry (e.g., alternate trade names.

Additionally, applicants must confirm in writing every three years that no changes have been made:

• Information supplied still applies precisely to substance/preparation being manufactured/supplied under the specific trade name.
• All laboratory tests and data referred to in Annex I to the OSPAR Recommendation on HOCNF are either in compliance with REACH registration requirements or European Chemicals Agency (ECHA) guidance.

Commentary

These complex, multifaceted regulations seek to protect the marine environment through various enforcement tools and reflect substantial progress in this arena. Application processes, although product-specific, are heavily component focused and strongly linked to various aspects of REACH. Additionally, procedures vary substantially based on jurisdiction, and it is vital to know the regions you wish to pursue and determine in advance who the Competent Authority is to ensure all issues are addressed appropriately. If additional product or substance level data are needed to complete the HOCNF process, implications must be considered for structurally similar substances/products as testing repercussions can extend beyond the original substances tested to substances of similar structure or product groups. It is also important to understand and anticipate risk when carrying out any testing for this process as it may overlap with other regional requirements.

Acta can assist companies in conducting preliminary reviews of substances against the OSPAR specific lists, determining REACH compliance, analyzing data gaps and arranging for any required testing, as well as assisting with application processes and communicating with Competent Authorities.