"Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC", in short REACH, was published in the Official Journal of the European Union on 30 December 2006. A corrected version was published on 29 May 2007.

REACH entered into force on 1 June 2007. As a Regulation it became directly effective in the Member States. Since it has also been adopted by the European Economic Area (EEA) countries, Iceland, Norway and Liechtenstein, it is effective in these countries as well.

The REACH Regulation and its Annexes are supplemented by Technical Guidance Documents, which have been published by the European Chemical Agency (ECHA).

REACH replaced a number of regulations and directives concerning existing substances and the notification of new substances. Core elements of REACH are registration and authorisation. After certain deadlines set by the Regulation, substances, including petroleum substances, can no longer be manufactured and/or imported if they have not been registered. The deadline for the registration of phase-in substances manufactured or imported in quantities of 1.000 t/a or more at least once after 1 June 2007, is 30 November 2010. This deadline also applies to substances that are carcinogenic, mutagenic or reprotoxic, and manufactured or imported in quantities reaching 1 t/a or more as well as to substances which may cause long-term adverse effects in the aquatic environment (R50/53) in accordance with Directive 67/548/EEC that are manufactured or imported in quantities reaching 100 t/a or more. In addition carcinogenic, mutagenic or reprotoxic substances, substances that are persistent, bioaccumulative and toxic or very persistent and bioaccumulative, and substances of "equivalent concern" may become subject to an authorisation procedure. However, some of these substances are exempted from authorisation; in the case of petroleum substances if they are used, for example, as fuel in fixed or mobile combustion units.

All phase-in substances had to be pre-registered with the European Chemical Agency by 1 December 2008.

EC Regulation 1272/2008 on Classification, Labelling and Packaging, the so-called CLP Regulation entered into force on 20 January 2009, replacing Directive 67/548/EEC (Dangerous Substances Directive, the “DSD”), Directive 1999/45/EC (Dangerous Preparations Directive), and REACH Title XI (Classification & Labelling). All substances will have to be classified and labelled in accordance with the CLP Regulation by 30 November 2010. Registration Dossiers submitted before the registration deadline of 30 November 2010 will have to include classification in accordance with both the DSD and the CLP. Both DSD and CLP classifications will need to be provided on Safety Data Sheets during the transitional period ending in 2015.

CONCAWE has drawn up an inventory of petroleum substances, which can be downloaded here.

Building on its Risk Assessment Programme (see web page on Petroleum Products), CONCAWE has a programme in place under which it develops for its members not only those parts of REACH Registration Dossiers for which agreement amongst registrants is obligatory and which have to be submitted to the ECHA by a Lead Registrant, but also all other parts of the Registration Dossier which can be submitted jointly on a voluntary basis.

Petroleum substances (except sulphur) are recognised by REACH as substances of “Unknown or Variable composition, Complex reaction products or Biological materials” (“UVCBs”). UVCBs are notoriously difficult to assess for their intrinsic properties and, where applicable, risks. For its comprehensive Risk Assessment Programme on Petroleum Substances, CONCAWE has developed methodologies that allow such assessments.

Note: The CONCAWE Risk Assessment Programme covers most, but not all petroleum substances listed in the Official Journal of the European Commission OJ L 84 of 5 April 1993. It does, for example, not cover steamcracker products, hydrocarbon solvents, lubricating greases, and re-refined base oils.

There are other REACH related issues which are of particular relevance or unique for petroleum substances, for example:

• Who in the supply chain is the importer under REACH and is therefore obliged to register an imported substance?
• Which processes can be regarded as manufacturing of substances under REACH and therefore oblige the operator to register the manufactured substance(s)? Which processes constitute making a preparation?
• How can imported petroleum substances be identified in terms of CAS Registry or EC number? How to avoid that importers can no longer import a substance only because they have registered a different CAS/EC numbers?

CONCAWE member companies have decided to make best use of CONCAWE’s comprehensive Risk Assessment Programme for Petroleum Substances in the preparation of the common parts of REACH Registration Dossiers. They have therefore also agreed to fully collaborate in the registration process and to exploit the possibility of joint submission of common parts of the Registration Dossier to the maximum possible under the REACH Regulation. This includes the preparation of Chemical Safety Reports.

The REACH Regulation foresees collaboration of all registrants of the same substance.

1. As a minimum, (robust) study summaries, classification and labelling and testing proposals have to be submitted jointly through a Lead Registrant.
2. It is mandatory to share certain substance data among all registrants of the same substance.
3. However, CONCAWE member companies have agreed to invite non-members to participate in the joint submission of the common parts of the Registration Dossier to the maximum possible extent under the REACH Regulation.

CONCAWE therefore intends to offer the common parts of the Registration Dossiers, including Chemical Safety Reports, under a suitable contractual framework e.g. in the form of licence agreements and against financial compensation. Such licence fee would represent in a fair, transparent and non-discriminatory manner a contribution to the investment that CONCAWE members have made in order to develop and implement the Risk Assessment Programme.

Click here to find the Inventory of Petroleum Substances for which CONCAWE will prepare the common parts of the registration dossiers. The substances are grouped by category. Please note that in a few aspects, the Inventory may be subject to change (see notes at the top of the Inventory and aside to each substance).

Importers should consult the “Shortlist and Reference Matrix of import CAS / EC numbers” (see Section 6).

Non-member registrants accepting CONCAWE’s offer would have to supplement the Registration Dossiers with their company specific data.

Non-member companies that are Manufacturers according to the REACH definition will have to supplement the Chemicals Safety Reports with the risk assessments for their own manufacturing sites.

In addition, Exposure Scenarios for any uses not covered by the jointly submitted Chemical Safety Reports will have to be developed and included by the registrants in a supplementary Chemical Safety Report for separate submission.

CONCAWE will prepare the common parts of the Registration Dossiers for the following “categories of substances” (status 21 September 2009):

1. low boiling point naphthas / gasolines
2. kerosines
3. straight run gas oils
4. vacuum gas oils, hydrocracked gas oils and distillate fuels
5. cracked gas oils
6. other gas oils
7. heavy fuel oil components
8. white mineral oils
9. unrefined / acid treated oils
10. other lubricant base oils
11. foots oils
12. paraffinic and hydrocarbon waxes
13. slack waxes
14. petrolatums
15. untreated distillate aromatic extracts
16. treated distillate aromatic extracts
17. residual aromatic extracts
18. bitumen
19. petroleum coke

In addition CONCAWE will prepare the registration dossier for sulphur.

Grouping the substances into categories allows read across of intrinsic (hazard) properties between the substances within a category.

This approach effectively means that information would be shared at category level rather than individual substance level. The various Substance Information Exchange Fora (SIEFs) for petroleum substances in the same category have been combined in “Super-SIEFs”. The 19 categories of petroleum substances are therefore being dealt with in 19 Super-SIEFs.

Because of the extensive overlap of gases from refinery operation and gases from steamcrackers and/or aromatics production units CONCAWE has agreed to collaborate with by the Lower Olefins/Aromatics consortium (LOA). The common parts of the registration dossiers for petroleum gases will be prepared by LOA.

For practically all petroleum products and for sulphur CONCAWE has volunteered as the SIEF Formation Facilitator and this role has been recorded in the REACH-IT system of the ECHA.

However, CONCAWE felt that it was necessary to start the collaboration process before 1 June 2008 when the pre-registration phase started, and therefore organised a Pre-SIEF Conference for Petroleum Substances. This conference took place on 23 May 2008 in Brussels.

The objective of the conference was not just to raise awareness of obligations under REACH and their interpretation, but to start addressing issues related to information sharing and communication between registrants, specifically for petroleum substances. The conference papers are available here.

CONCAWE in its role as SIEF Formation Facilitator: Has established which pre-registrants intend to follow up their pre-registration(s) by registration(s), in which volume band and by which of the three deadlines (2010, 2013, 2018).

Will provide a SIEF communication tool; until this is fully operational CONCAWE, in its role as SIEF Formation Facilitator, will communicate with SIEF participants by e-mail.

Has collected relevant and reliable substance data from registrants and other data holders

Has initiated additional testing, i.e. testing that is required before registration

Has formed the “Super-SIEFs”

Will identify a Lead Registrant for each petroleum substance and sulphur (for most petroleum substances CONCAWE member companies will act as Lead Registrants).
CONCAWE will share the SIEF facilitation costs among registrants in a fair, transparent and non-discriminatory manner.

After the composition of the petroleum substances SIEFs had been downloaded, CONCAWE in its role as SIEF Formation Facilitator had sent to the contact e-mail addresses recorded in REACH-IT a comprehensive initial communication. The paper addressed the category approach, the need for Super-SIEFs, the sameness check, the scope of the common parts of the registration dossier CONCAWE is preparing, the licence under which these dossiers will be offered to all registrants etc.. Attached to this communication was a simple response form where pre-registrants were asked to confirm (or not) that they intend to follow up their pre-registration by a registration and if so by which deadline/in which volume band.

Even after having sent a reminder the response rate was disappointing, an experience that CONCAWE shares with many other SIEF Formation Facilitators.

As a consequence CONCAWE will regard all pre-registrants who have not responded to the survey as “dormant”, i.e. as having no intention to register. This policy is being supported by the European Chemical Agency. In order to avoid that pre-registrants with faulty or outdated contact e-mail addresses recorded in REACH IT miss this important information the following text has been posted for all petroleum substances and sulphur:

"Pre-registrants who have pre-registered before the deadline of 1 December 2008 and not deactivated their pre-registration should have received at the e-mail address recorded on this Pre-SIEF page a comprehensive document describing – inter alia – the approach to the joint submission of the registration dossier and addressing the issue of sameness of substances. They have also received a short questionnaire.

Pre-registrants that have responded and confirmed their intent to register have received additional information with respect to the sameness of substances and will receive regular newsletters."

Already the discussions at CONCAWE’s Pre-SIEF Conference confirmed that the identification of petroleum substances imported into the EU is a concern. To facilitate this process, CONCAWE member companies have developed a “Shortlist” of Chemical Abstract Service Registry Numbers (CAS RNs) for petroleum substances that are commonly imported into the European Economic Area (EEA).

A total of 50 Shortlist CAS numbers have been identified covering all of the major classes of petroleum substances, e.g. straight run kerosines, light cat-cracked naphthas, heavy cat-cracked naphthas, white mineral oils, etc. Since the list has been developed only for commonly traded petroleum products, it is possible that an importer will not be able to assign a CAS RN from the Shortlist to all imports. It is the registrant’s responsibility to ensure that any chosen Shortlist number is an appropriate descriptor for the cargo that is being imported.

The Shortlist (Excel file) provides further details and is composed as follows:

1. Tab marked “Shortlist”
   Provides details of the 50 Shortlist CAS numbers nominated, together with their full official definitions.
2. Tab marked “Lookup list”
   Gives a full listing of petroleum product CAS numbers, grouped by the main classes:
   • Column A: simple code which defines whether, for the particular CAS RN, a Shortlist CAS RN has been identified that might describe the cargo:
     • code “✓” if a Shortlist number has been identified;
     • code “X” if none could be identified;
     • code “S” if the particular CAS RN is a Shortlist number itself.
   • Columns B - G: CAS RNs and their official definitions.
   • Column H: proposal for Shortlist number (where one has been defined) that might be considered to describe the cargo.

CONCAWE emphasises that the Shortlist, and the attached references to other CAS numbers, must NOT be regarded as a recommendation. It is simply a list that may be helpful in assigning CAS RNs to imported cargoes of petroleum substances. As such it may be helpful to importers in their obligations to comply with the REACH Regulation.

Please note that it is not CONCAWE’s intention to necessarily include all CAS RNs identified in the “Shortlist” or in the “Lookup” list in their work to develop risk assessments and REACH registration dossiers.

CONCAWE member companies will apply the principles explained in the following three papers regarding the treatment under REACH of oil-field chemicals and additives that may be present in crude oils, natural gas condensates, and fuel/blending streams that are imported into the European Economic Area:

• Chemicals Used in Crude Oil Production and Impact for Imported Crudes
• Chemicals Used in Condensate Production and Impact for Imported Natural Gas Condensates
• Additives in liquid hydrocarbon fuels and blending streams imported into the EU under REACH

Crude Oil and Natural Gas Condensates are exempted from the obligation to register in accordance with Article 2(7)(b) of REACH (Annex V). Two papers discuss the nature (and likely concentrations) of any residual levels of oilfield chemicals and additives which are likely to be present in these substances, along with their status under REACH. The third paper addresses the presence of chemical constituents of additives in imported refinery streams and fuel products.

Recognising the practical difficulties of identifying these constituents in imported cargoes, a working group of CONCAWE member companies has prepared these three position papers in order to provide practicable guidance to member companies in addressing these challenges.

On 27 November 2008 CONCAWE provided the three above-mentioned papers to the ECHA for information. Please find here the response dated 18 December 2008 received by CONCAWE from Mr. G. Dancet (ECHA).

CONCAWE has mapped Identified Uses against Generic Exposure Scenario titles and the Use Descriptor System. The list can be found here.

(This section will be supplemented as additional papers become available)

• REACH guidance documents
• Strictly Controlled Conditions for Intermediates: Guidance and Examples
• Classification & Labelling update: V2.0, 20.7.10
• ECHA Questions & Answers
• Papers from the Pre-SIEF Conference for Petroleum Substances, 23 May 2008
• Paper presented at ECHA’s Lead Registrant Workshop on 11 September 2009

For more information, send an e-mail.