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Denehurst Chemical Safety Ltd

New Substances


Transition from NONS to REACH - supply of new substances from 2008

 

REACH came into force 2007, but until June 2008, most of the ‘old' legislation still applied. After June 2008, action has been required for those supplying new substances (‘non-phase in), but just how different is life under REACH ?  Is it really going to be better for those innovating in new substances ? 

To look to the future, it is important to look back and many of the concepts under REACH are
based on old legislation.

Legislative basis

In 1967, the first major piece of European chemical supply legislation was published which set the framework for the control of dangerous chemicals.  With the exception of finished pharmaceuticals, direct food additives, radioactive substances, ammunition etc, the Dangerous Substances Directive 67/548/EEC, and the myriad of Directives spawned from it, formed the basis of all subsequent chemical control Directives. Understand these and the rest is (relatively) easy.


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 28th 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 28th 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.



Directive 67/548/EEC and its amendments

REACH

List of substances supplied

EINECS

Pre-registration


Notified substances

Listed on ELINCS

Considered registered in the name of the Notifier

Exempt materials

Finished pharmaceuticals, food additives, plant protection products etc.

Finished pharmaceuticals, food additives, plant protection products etc.

Same.

Non-isolated intermediates

Exempt

Exempt.

Same.

Isolated (on-site) intermediates

Exempt

Registration required with reduced data

Transported intermediates

Full Notification, but possible exemption from some testing

Registration required with reduced data

Export to outside EU only

Exempt

Registration required


Process research

(eg. supplying material to test systems and offer trials to customers)

PORDs submitted to each Member State CA with justification for 1 year supply

PPORD through central EU agency with longer periods possible

Supply of 10kg - 1000 kg

Reduced Notification

Exempt


Supply of 1 - 10 tonnes

Full Notification

Reduced data set


Supply of over 10 tonnes

Higher level Notification

Full registration

Notification / Registration

Notification:

Completion of SNIF software and submission documents sent to national agency with test reports.  Supply could only start after reports and dossier accepted.

Registration:

Electronic submission of IUCLID 5.  Supply to start after 3 weeks if no comments resulting from completeness check. 

Fees

Up to € 7000 in some member states for supply of over 1 tonne

EU harmonised fees depending on size of registrant and tonnage.
Free for under 10 t

Performing tests

Testing to follow prescribed lists unless waivers agreed

Testing to be based on lists, but to provide sufficient data for risk evaluation and classification.  Permission required to conduct tests on animals.

Data waivers

Agreement should be reached with national CA before Notification

Justification to be provided with registration

Changes in supply

National CAs need to be informed of changes and fees may apply in some cases.  Increasing volume of supply above thresholds of 10, 100 or 1000 tonnes would need further testing.

European Agency needs to be informed of changes and fees may apply in some cases.  Increasing volume of supply above thresholds of 10, 100 or 1000 tonnes would need further testing.

Same

Importer status

Importers to Notify or non-EU suppliers can appoint ‘Sole Representatives'

Importers to register or non-EU suppliers can appoint ‘Only Representatives'.

Effectively the same.

Polymers

At least 3 repeat units exempt (if < 50% any single unit molecular weight).

At least 3 repeat units exempt (if < 50% any single unit molecular weight).

Same

Risk assessment

Required for supply of over 1 tonne of new substance to include manufacturing and use details, including applications by downstream users.

Required for supply of over 1 tonne of new substance to include manufacturing and use details, including applications by downstream users.

Same but new format for CSR

SDS

16 point SDS that included references to types of use anticipated in preparing the SDS.  Note that most SDSs failed to meet requirements.

Slight format changes, and need to provide more details of use scenarios relevant to the SDS.

Basically the same.

Classification


Pictograms and hazard phases with arbitrary cut-off values for categories of hazard.  Classification of mixtures determined by comparing relative concentrations of hazardous components.


Pictograms and hazard phases with arbitrary cut-off values for categories of hazard.  Classification of mixtures determined by comparing relative concentrations of hazardous components.

Same concepts, different symbols and phrases with GHS

Data sharing

If supplying a substance already Notified, the second supplier would need to share animal data and the primary Notifier could withhold such data.  Industry would need to come to an agreement to share costs

If supplying a substance pre-registered or registered by another supplier, the second supplier would need to share animal data and the primary Notifier could withhold such data.  Industry would need to come to an agreement to share costs


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.


Supply scenario


Pre-REACH status

REACH status

Not on EINECS, NLP or otherwise exempt and not Notified and supply planned.


For supply over 10 kg, you need to consider immediate Notification.

For supply over 1 tonne, you need to consider immediate registration as non-phase in.

Pre-registration is not an option.

EINECS listed, NLP


Anyone can supply

Anyone can pre-register and once pre-registered, supply continues until registration date set be tonnage threshold

Export only supply and site limited isolated intermediate

Anyone can export out of EU or keep intermediates on site

Anyone can pre-register and once pre-registered, supply continues until registration date set be tonnage threshold

ELINCS listed (or recently Notified and ELINCS not yet assigned) for supply within EU of 10 - 1000 kg

Supply limited to Notifier only.



Supply over 10 kg needs Notification by second supplier and animal test data must be shared.

No status under REACH.  Anyone can supply up to 1000 kg


Supply over 1 tonne needs immediate registration (pre-registration not possible, unless previously supplied for export only or produced on site as an intermediate)

ELINCS listed (or recently Notified and ELINCS not yet assigned) for supply within EU of > 1 tonne

Supply limited to Notifier only.



Supply limited to Notifier only.


Supply over 1 tonne needs immediate registration (pre-registration not possible, unless previously supplied for export only or produced on site as an intermediate)

PORD in place

Supply only to nominated recipients for limited period

PORD is cancelled and PPORD must be applied for.

Change of supplier

Repeat Notification required (for new supplier in EU).

Demonstration of equivalent substance identity if change of non-EU supplier in case o import

Registration required as non-phase in for new EU supplier after June 2008.

Demonstration of equivalent substance identity if change of non-EU supplier in case o import and ECHA to be informed.

Not on EINECS, NLP or otherwise exempt and not Notified and supply already taking place


For supply over 10 kg, you are breaking the law and should cease supply or ask the relevant national CA to be lenient while a Notification is made. 

For supply over 1 tonne, you need to consider immediate registration as non-phase in.  Pre-registration is not an option.



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.