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Denehurst Chemical Safety Ltd

Pre-REACH compared with REACH

REACH is perhaps not so different........

 

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.


A list of frequently cited Directives is given below and most of these have added to the gene pool of REACH.  An early political paper on REACH is also cited and this lays out the concepts of REACH and the reasons we have it.  Understand these and the rest is (relatively) easy.


Directive 67/548/EEC               The ‘mother' Directive; describing the need to regulate chemical supply in Europe and laying down the requirements for Notification and classification and labelling

Directive 88/379/EEC               First preparations Directive

Directive 91/325/EEC               Classification and labelling (see 93/21/EEC)

Directive 91/155/EEC               Specification for safety data sheets

Directive 92/32/EEC                 Seventh amendment to 67/548/EEC which changed the rules for Notification into their current form

Directive 92/69/EEC                 Annex V of 92/32/EEC describing test methods

Directive 93/21/EEC                 Classification and labelling of substances updated to include environmental classification

Directive 93/67/EEC                 Describes the principles for risk assessments

Directive 98/8/EC                     Biocides Directive, outlining the provisions for the regulations of non-agricultural pesticides, disinfectants, preservatives etc.

Directive 1999/45/EC                Revised Preparations Directive, to include environmental classification and increasing the scope of chemicals covered (eg. biocides and agrochemicals)

Directive 2001/59/EC                The 28th adaptation to 67/548/EEC concerning the supply of chemicals.  Includes proposals for reduced testing for site-limited chemicals (eg Pharmaceutical intermediates)

COM(2001) 88 Final                 27 February 2001.  New European White Paper ‘Strategy for a future chemicals policy'.



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

Free for under 10 t (correct dossier)

€ 4300 maximum for up to 100 tonnes

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

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.

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.  However, 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


Current (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 in May 2008.


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 substance 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 notification (until June 2008) or registration (after June 2008) is made. 



Classification and labelling

As part of the implementation of the dangerous substances Directive 67/548/EEC, chemical substances and preparations need to be classified and labelled to indicate potential hazard to users. When Directive 67/548/EEC was amended for the seventh time (Directive 92/32/EEC), the concept of environmental classification was introduced and is described in detail in Directive 93/21/EEC which covers the current principles of classification and labelling of substances. 


For mixtures of substance, the original Preparations Directive 88/379/EEC has been replaced by a new Dangerous Preparations Directive 1999/45/EC (New DPD), which, introduces environmental classification and labelling. In appreciation of the difficulties faced by industry, the implementation of the Directive is not until 30 July 2002 (plant protection products and biocides, 2004) more than three years after publication.  Enactment in the UK will be through the Chemicals (Hazard Information and Packaging for Supply) Regulations (acronym CHIP).  The latest changes will be published as CHIP 3.


Annex I of Directive 67/548/EEC (and its subsequent amendments) is a list of Dangerous Substances that defines the appropriate classification and labelling.   This is reproduced in the British Approved Supply List, making up part of the CHIP regulations and provides the basis for in determining the correct classification and labelling for mixtures.  Annex I will in turn be replaced by the ‘Classification and Labelling Inventory'.


Note that GHS will not change the concepts of estimating hazards for EU supply, although the use of symbols and phrases will change.


Transport labelling

International transport is controlled by UN and in many cases there is a conflict between UN and EU classification points.  This can lead to confusion in which the classification indicated on the exterior packaging during transport will be different to the classification on interior packaging intended for consumers (ie. external labels are controlled by UN legislation and internal packaging by EU legislation).


Although certain dangerous substances are identified by specific ‘UN Numbers', the UN process is based on a series of pictograms.  Codes are also assigned to classes of substances (such as flammable liquid, corrosive solid etc) which provides simple and quick advice to emergency workers on the scene of an accident.  Handbooks are available which confirm the assignment of correct codes for classes of chemicals.


There are currently discussions taking place within OECD countries to harmonise classification, especially with respect to definitions of ‘toxic', ‘irritating', corrosive etc.  For example, the criteria for considering a substance as ‘toxic' under UN labelling is not the same criteria required for ‘toxic' by EU classification.


A major point of discussion is conflict between the EU and US on the use of LD50 testing instead of estimating toxicity by assigning the substance to an appropriate toxic class.


Pollution control / Environmental contamination

Two pieces of legislation are coming into force in 2001 / 2002 concerning the management of production processes to prevent major accidents and environmental contamination.  The legislation is based on IPPC (Integrated Pollution Prevention and Control) and COMAH (Control of Major Accident Hazard Regulations). 


Both of these require knowledge of the chemical processes taking place on any particular site where chemicals are used and knowledge of the identity of the chemicals involved, irrespective of the final use of the chemical product.


Conclusions

Many of the concepts of legislation are not changing and other than the need to register export only or on-site isolated intermediates, life may actually be slightly easier under REACH if manufacturing or importing new substances.  For those supplying for process research or supplying under 1 tonne, it is certainly better.


The issues of fees, understanding DUs use patterns, writing risk assessments and entering test data onto complex software is familiar to all those who have been involved in supply of new substances over the last 20 years or so. 


Most other aspects such as transport, SDSs, labelling and other legislation remain effectively unchanged.  REACH is creating a lot of work, but perhaps it is not as complicated as it seems from reading the volumes of legal text and guidelines.

Denehurst - supporting industry
info@denehurst.co.uk