The key part of Directive 67/548/EEC was to make suppliers of chemicals submit a list of substances they manufactured or imported with details of chemical identity, and the final list was known as EINECS - European Inventory of Existing Chemical Substances.  Effectively, this was the same as the ‘pre-registration' phase of REACH.

Any substance not listed on EINECS (the list closed in 1983) was considered a ‘new substance' and Notification was necessary.  The legacy of this with REACH is that the new substances are now considered registered under REACH and those on EINECS are the ones that need to be reviewed.  Unfortunately, there are some complications in the process of transition and it is these that this document tries to address later. 

Some of these complications arise from the exemption to Notify if exported from the EU and the exemption if used as an on-site isolated intermediate.  A further complication was caused by a change in rules for polymers during the Seventh Amendment to 67/548/EEC, and substance omitted from EINECS as they were then considered polymers, subsequently needed listing as ‘no longer polymers' (NLP).  Interestingly, this list remains open until June 2008.

Notification of New Substances - NONS (1967 - June 1 2008)

A scheme to Notify government agencies of the intention to import, produce or market new Chemical Substances exists in virtually every country in the World. The basic principles applied are covered by the Pre-Manufacture Notification, such as that implemented in the US under the Toxic Substances Control Act (TSCA) or the Pre-Marketing Notification such as the scheme in Europe.  In some countries, like Canada, there has been a bit of a compromise between the two, and REACH itself has takes on board some useful lessons for other systems, notably the Japanese concern for persistence and bioconcentration or the need to register isolated on-site intermediates (as in the US TSCA).

In Europe, as legislation was covered by a ‘Directive', legal enforcement was based on national government legislation and these national agencies (Competent Authorities) needed to be informed of the intention to place New Chemical Substances on the market as originally described in Directive 67/548/EEC.  This Directive has been subject to a number of subsequent amendments and the most recent, the 28^th Adaptation, is designed to reduce testing requirements for limited supply substances such as pharmaceutical intermediates.  This is taken further under REACH with potentially reduced test requirements for all intermediates.

The Notification process is based on the need to submit for review a package of data on the new substance to the appropriate Competent Authority.  The conclusion of the submission is in the form of a risk assessment, providing recommendations for the labelling and safe use of the new substance.  Once notified, the substance was listed on ELINCS (European List of New Chemical Substances) and this list was specific to the Notifier.  Changes in proposed uses patterns or levels of supply had to be reported to the CA.  

The company responsible for its introduction on the market in the EU (either the manufacturer or importer) had to inform their national Competent Authority.  In the case where a substance is custom manufactured on behalf of another company, the manufacturer and not the sponsor is responsible and the Notification will need to take place in the country of that manufacturer. The transfer of chemical intermediates to be supplied to different sites within the same organisation is considered to be an act of supply, but intermediates isolated and kept on one site were exempt.  Non EU manufacturers could appoint ‘sole representatives' with the same status as ‘only representatives under REACH.

If the total quantity of a new substance introduced commercially is under 1 tonne per annum throughout the EU, a low volume Notification could take the place of a full Notification.  Sales could not exceed 1 tonne per annum in total throughout the EU or exceed 5 tonnes in total cumulative until base-set studies were conducted, reported and a full Notification package submitted to the national CA - even then, supply could not take place until the dossier was accepted and either way, a delay of a minimum 2 months was required before supply. 

If the volume reached 10, 100 or 1000 tonnes per annum, the competent authority had to be informed and further testing was necessary.

The 28^th adaptation to Directive 67/548/EEC (Directive 2001/59/EC), describes a reduced test data set for site-limited chemicals, such as pharmaceutical intermediates.  Effectively, an Annex VIIB data set will suffice for ‘low risk' substances. Even now, there is still discussion between EU Competent Authorities as to what constitutes a low risk substance, but it Notifications with a reduced data set were accepted from July 2002.  This ‘low risk' debate will no doubt continue under REACH.

Exemptions can be applied for if the substance is to be used for research.  Exemptions can be granted for ‘process orientated research and development' (PORD) where scale-up from laboratory to factory is taking place.  Such exemptions must be fully justified and a minimum data set is expected.  In addition, material supplied under an exemption must not be passed on to the general public nor offered for commercial sale.  REACH replaces this with the ‘PPORD'.

Summary of changes

The table below describes the ‘old' and ‘new' processes for chemical supply.

Status of Notified substances

Substances that have been Notified under NONS will be ‘considered' registered and will be given a registration number by December 2008.  These need to be applied for by the rightful owners using the REACH IT system.  Only those who Notified will be given registration numbers and only these ‘registration holders' can supply the substances - if other suppliers want to supply the substance, they will need to prepare an immediate registration as a ‘non-phase in' substance and share data with the Notifier.

The table below describes the scenarios.  The term ‘supply' relates to manufacture or import.

It is therefore clear that many manufacturers and importers of new substances will need to consider registration in 2008 as pre-registration is not an option.   The act of pre-registration will undoubtedly identify many substances that have slipped through the regulatory process and should have been Notified - these substances need to be withdrawn from the market until a  registration is made.