REACH pre-registration andregistration requirementsfor imported alloysJune 2008

REACH pre-registration and registration requirements for imported alloys2

This leaflet is intended to be a faithful summary of the ‘Guidance on Pre-registrationand Registration for MetallicAlloy Manufacturers andImporters’ prepared by theEuropean Industry Metallic Alloys Group (EIMAG) inSeptember 2007. The full version containing additionalinformation on this topic isavailable at: www.reach-metals.eu

REACH is the new EU chemicals legislation thatwill manage the safe use of chemicals throughouttheir entire life cycle. The system consists of fourpillars: Registration, Evaluation, Authorisation andRestriction of Chemicals.

It will apply to all substances - on their own, inpreparations and in articles that are manufacturedin or imported into the European Economic Area(EEA)1 in quantities of 1 tonne or more per year.REACH will require substances within the scope of the regulation to be registered in order to have the right to place them on the EEA market.Pre-registration and registration will apply directlyto metals, metal compounds on their own as wellas when they are incorporated in alloysmanufactured, used and imported into the EEA.The requirements do not apply to minerals, oresand ore concentrates as long as they are notchemically modified2.

The majority of metals are placed on the market asmetallic alloys3. Recital 31 of the REACH regulationrecognises that metallic alloys are specialpreparations, as their properties, behaviour, andcharacteristics are different from those of theconstituent substances.

Metallic alloys can be manufactured by differentmanufacturing routes, but the two most commonmethods are:

Melting Where metals and other substances are meltedand mixed together (there is no intentionalchemical reaction between the substances); and

Smelting Where one or more ores or ore concentrates areheated and reduced (i.e. chemically modified) bye.g. aluminino-carbon-silico thermic reduction – to manufacture and mix the metals in one step, orby electrolysis. Examples of smelted alloys areferro-alloys, master alloys and mischmetal.

The aim of this leaflet is to inform importers on:

• the pre-registration and registration requirements to be fulfilled for substances in alloys or for the alloy itself when considered as a multi constituent substance (MCS)

• the consequences of not complying with the REACH regulation for alloys that are imported into the EEA.

1. IntroductionImportant notice

DisclaimerThe author reserves the right not to be held responsible for the topicality, correctness, completeness or quality of theinformation provided. Liability claims regarding damage caused by the use of any information provided, including any kind of information that is incomplete or incorrect, will therefore be rejected.

2.2 What should be pre-registered?

There are two options for fulfilling pre-registrationrequirement for alloys.

Preparations route Pre-register each individual substance within thealloy (Article 28). In line with Article 6 of theRegulation, any manufacturer or importer of analloy will be required to pre-register all4 theindividual substances that are present in the alloyin total quantities of more than 1 tonne per year,independent of the concentration in which they arepresent in the alloy. The pre-registrant will then belisted on the Substance Information ExchangeForums (SIEF) for each one of the pre-registeredsubstances.

Multi Constituent Substance (MCS) route Pre-register the (smelted) alloy as a multi-constituent substance. Those alloys which are manufactured through intended chemical reactionscould be considered as multi-constituentsubstances5 under REACH. Each alloy can then be pre-registered as a substance on its own. This route applies only to alloys which:

• are formed by a chemical reaction (smeltedalloys); and

• are listed on the EINECS or whose constituents are listed on the EINECS.

Only the ‘preparations’ route is applicable to meltedalloys. For smelted alloys, the ‘preparations’ or the‘Multi Constituent Substance’ route can befollowed.

When an alloy contains substances that wereoriginally manufactured in the EEA but exportedout of the Area, and then re-imported within analloy, there is no need for the re-importer toregister those substances again, as long as:

(i) the substances have been registered before

(ii) the re-importer can demonstrate that each substance is the same as the one which was registered and originates from the same batch, and

(iii) the information specified in Articles 31 and/or 32 is made available and ensures a safe use of the substances in the alloy.

Until (i) can be confirmed, it is howeverrecommended to pre-register each substance ofthe alloy6 as a precaution.

2. Pre-registration requirements

REACH pre-registration and registration requirements for imported alloys 3

2.1 Who can pre-register?

As the pre-registration and registration of thesubstances in the alloy or the MCS (alloy as such)has to be made by a legal entity established in theEU, the pre-registration and registrationrequirements related to imported alloys can only be fulfilled by:

The importer of the alloyIn this situation, the importer should properlyidentify the non-EEA manufacturer of the alloy,obtain all the necessary information, and proceedwith pre-registration and subsequently theregistration; or

The Only Representative (OR) of the non-EEAmanufacturer of the alloyIf the non-EEA manufacturer decides to appoint an‘Only Representative’ (OR), then the alloy importerswill be considered as the downstream users (DU) ofthat OR under REACH; consequently they are notrequired to pre-register and later register thesubstances in the alloy or the MCS.

The OR will be fully responsible for pre-registrationand registration as they assume the fullresponsibility and liability of the importers onbehalf of the Non-EAA manufacturer.

The Non-EEA manufacturer is obliged to:

• inform all the importers in the supply chainthat an OR has been appointed

• provide the OR with up to date info on:

• list of EU importers covered

• the volumes imported.

The OR has to be able to document to enforcementauthorities at request, which importers he coversat EU and MS level. This information also includesdata on the volume covered per importer, but it isnot required to be submitted to the EuropeanChemicals Agency (EChA).

REACH pre-registration and registration requirements for imported alloys4

2.3 What should not be pre-registered?

Impurities7

The definition of a ‘substance’ in Article 3 of theREACH Regulation indicates that any impuritiesderiving from the process used for themanufacturing of the substance are part of theintrinsic constituency of a substance. Moreover, theguidelines of the EChA on registration state clearlythat only the substances intentionally added to apreparation need be registered. It can therefore beconcluded, and this was recently confirmed by theEC at a stakeholder event, that impurities that arepresent in a preparation, such as an alloy, do notneed to be pre-registered as a substance of thepreparation8, unless intentionally added.

Alloys as articlesPre-registration is not required when an alloywhich is placed on the EEA meets the definition ofan article9 from which substances are not intendedto be released under reasonable and foreseeableconditions of use. The latter condition is likely to bethe case for all alloys that can be regarded asarticles10 under REACH.

3.1 What to register and how?

Preparation of the registration dossierIn the event that the special preparations route isfollowed, the pre-registrant should prepare oneregistration dossier per individual substance.

In the event that both pre-registration routes arefollowed (in the case of smelted alloys), only oneshould be selected for the purpose of registration.The selection should be made by the potentialregistrant(s) based on the specific recommendationsand agreements reached within the applicableSIEFs. The decision should not lead to lesserprotection to human health and the environment.

Should the MCS route be chosen, the reasonssupporting this decision must be documented.Choosing the MCS route requires the registration ofthe substance as manufactured. This means thatthe data requirements need to be met for the MCSas a substance on its own and all the relevant testsneed to be performed on the MCS itself. However,there is no need to test the MCS if the hazardprofile of the substance can be sufficiently describedby the information of the individual constituents.

Preparation of the Chemical Safety Report (CSR)As alloys are regarded as special preparations, they require special methodologies for theirassessment. As mentioned above, it has beenrecognised that alloys do present properties and

REACH pre-registration and registration requirements for imported alloys 5

3. Registration requirements

characteristics that are different from those of thesubstances they incorporate.

It is therefore good practice to consider thefollowing approaches when preparing a CSR for theregistration dossiers:

a) Special preparations approach: When preparing the CSR for the purpose of registering each individual substance in the alloy, the exposure scenarios included in the CSR should reflect the use of the substance as an alloying element. The potential health and environmental impact of this use should take into account the effect of the substance in the alloy (for the purpose of the use in alloys) and the way the constituents are bondedin the chemical matrix of the alloy, rather than simply the effect of each substance on its own.

b) MCS approach: When the alloy is registered as a multi constituent substance, the health and environmental assessment of the alloy can consider the impact of the alloy as a whole (a substance on its own) or of its individual constituents.

Impurities do not need to be registered. However,impurities that are present in the substances of the alloy or the alloy itself in quantities above 0.1%(w/w), or less in cases where a lower limit isspecified in Annex I of Directive 67/548/EEC (e.g. CdSO4 0.01%), need to be taken into account in the CSR to demonstrate safe use.

REACH pre-registration and registration requirements for imported alloys6

3.2 Consequences of not pre-registering andregistering

To miss the pre-registration deadline for the alloy,either as substances in a preparation or as a multi-constituent substance, means loss of accessto the EEA market: ‘no data, no market’, i.e. noregistration dossier, no imports.

Should a non-EEA manufacturer intend tolegitimately market an alloy in the EEA after the pre-registration deadline without having pre-registered, they need to consider that:

• Registration requirements apply from 1 June 2008 (even if you may still pre-register until 1 December 2008).

• The importer or the OR of the non-EEA manufacturer will have to perform the registration before the import of the alloy can be continued beyond 1 June 2008.

• Manufacture, placing on the market and use of the alloy may be interrupted from 1 June 2008 until 3 weeks after completion of registration, during which the following processes must take place:

• the inquiry process: to determine whether any other manufacturer(s) intend(s) to register the substances in the alloy or the alloy as an MCS. The required data are outlined in Article 26 § 1

• submission of testing proposals for vertebrate animal studies that can not be performed with out prior consent of EChA

• submission of the Registration dossier

• completeness check of the registration dossier by the EChA.

Continuing to market or use an alloy without pre-registering, puts the manufacturer/importerand their clients at risk as marketing of thesubstance/alloy will be considered illegal andsubject to enforcement measures for non compliancethat are under development at Member State level.

Even if you do not pre-register, you are still boundto data sharing and joint submission of the coredata set for the substance.

End Notes1 The EEA consists of the 27 EU member states, and Iceland,Lichtenstein and Norway.2 Minerals, ores and ore concentrates that have not yet been chemically modified do not need to be registered. Nevertheless, some materials thatcompanies have traditionally referred to as ‘ores’ or ‘concentrates’ maynot be legally recognised as such under REACH.3 Alloy means a metallic material, homogenous on a macroscopic scale, consisting of two or more substances so combined that they cannot bereadily separated by mechanical means.4 Impurities do not need to be registered, also see section 2.3 for further clarification. 5 A multi-constituent substance is a substance defined by its composition, in which more than one main constituent is present in quantities between10 and 80% (w/w).6 When the MCS route is chosen, this is only valid if one pre-registers on basis of the individual substances of the alloy. 7 In the EChA guidelines on substances identification, an impurity is defined as an unintended constituent present in a substance asmanufactured. It may originate from the starting material or as a resultof secondary or incomplete reaction during the manufacturing process.While it is present in the final substance it was not intentionally added. 8 Care must be taken to fully document both the position taken regarding impurities and the rationale behind the decision to not pre-register theimpurities contained in the alloy.9 Article means an object which during manufacturing is given a special shape, surface or design which determines its function to a greaterdegree than its chemical composition.10 For further guidance please refer to the EChA guidance document on substances in articles. This guidance contains an example for aluminiumin which the borderline between a substance or preparation and an articleis drawn. For other metals it remains a case-by-case interpretation, whosearguments and rationale should be fully documented.

4. Key deadlines

REACH pre-registration and registration requirements for imported alloys 7

4.1 Pre-registration

As most or all metals or metal compounds areexisting substances, the manufacturers of alloysare able to benefit from the phase-in provisions, on condition that a pre-registration is performedbetween 1 June and 1 December 2008.

4.2 Registration for non phase-in or nonpre-registered phase-in substances

The deadline for registration of non-phase-insubstances or phase-in substances for which a pre-registration will not be submitted was the 1 June 2008. The only cases where this would beapplicable are:

• Preparations route: in the event not all substances in the alloy are phase-in substances.

• MCS route: in cases where the MCS or not all the constituents in the alloy have an EC-number.

4.3 Registration for pre-registered phase-insubstances

The pre-registrant will be able to benefit from atransitional period allowing them to prepare aregistration dossier and submit it to the EChA bythe deadlines specified in Figure 1 below as afunction of the manufactured volume and theclassification of the substance.

Additional information on metals consortia, thelatest information from EC and EChA, guidance and REACH activities in the metals industry can be found on the REACH metals Gateway(www.reach-metals.eu).

Figure 1: Overview of the pre-registration and registration timelines

1 June 2007

Entryinto

forc

e

1 June 2008

Entryinto

operatio

n

1 Decem

ber 2008

30 Novem

ber 2010

31 May 2013

31 May 2018

Set-up of Europe Chemicals Agency

Pre-registration

Registration of:≥ 1 tonne/year CMRs≥ 100 tonnes/year very toxic to the aquatic environment≥ 1000 tonnes/year

≥ 100 tonnes/year

≥ 1 tonne/year

New substances

ICMM35/38 Portman SquareLondon W1H 6LRUnited Kingdom

Phone: +44 (0) 20 7467 5080Fax: +44 (0) 20 7467 5081Email: info@icmm.com

www.icmm.com

EurometauxEurometaux constitutes the interface between theEuropean non-ferrous metals industry and the Europeanauthorities and international or intergovernmental bodies.It is committed to establishing dialogue with the latter inorder to ensure early consultation in all fields of policy andlegislation that may affect industry and to asserting thesector’s views and positions in this respect. It asserts thecontribution of the European industry and its products tosustainable development, as well as this industry’s viewsand positions, whenever the opportunity to do so arisesacross all sectors of society.

www.eurometaux.org

ICMMThe International Council on Mining and Metals (ICMM) is a CEO-led industry group that addresses key prioritiesand emerging issues within the industry. It seeks to play a leading role within the industry in promoting goodpractice and improved performance, and encouragesgreater consistency of approach nationally and acrossdifferent commodities through its association membersand member companies. ICMM’s vision is for a respectedmining and metals industry that is widely recognized asessential for society and as a key contributor tosustainable development.

For further information on industry initiatives on hazardand risk assessment, including MERAG and HERAG, visit:www.metalsriskassessment.org

REACH pre-registrationrequirements June 2008

REACH pre-registration requirements 2

REACH is the new EU chemicalslegislation that will manage the safe use of chemicalsthroughout their entire life cycle.The system consists of fourpillars: Registration, Evaluation,Authorisation and Restriction ofChemicals.

It will apply to all substances, on their own, inpreparations and in articles, that are manufactured in or imported into the European Economic Area(EEA) market in quantities of 1 tonne or more per year.

In the first instance, REACH will require mostchemicals within the scope of the Regulation to beregistered in order to have the right to manufactureand access the EEA market. Pre-registration andregistration apply directly to metals, metalcompounds and metals in alloys manufactured inand imported into the EEA. They do not apply tominerals, ores and ore concentrates provided thatthey are not chemically modified1.

For non phase-in substances, i.e. substances thathave not been manufactured or imported in theEEA over the last 15 years, registration will berequired before manufacture or import of thesubstance in the EEA. The phase-in (or existing)substances however can benefit from extendedregistration deadlines if they are pre-registered.

The REACH Regulation entered into operation on 1 June 2008, with the pre-registration of phase-insubstances and the registration of non phase-insubstances.

The scope of this leaflet is to outline howcompanies producing metals, metal compoundsand alloys can meet their pre-registrationobligations with the aim of retaining access to theEEA market during the transition period betweenthe pre-registration and registration deadlines.

Pre-registrationIntroduction

1. What is a pre-registration?

Pre-registration is a purely administrativeprocedure. All companies producing and importingthe relevant substances on their own, inpreparations or in articles with an intendedrelease, in quantities of 1 tonne or more per year,will have to pre-register by submitting a limited setof information to the European Chemicals Agency(EChA). This will enable companies to benefit froman extended registration deadline, depending onthe tonnage band (see Figure 1).

Companies will retain the right to manufacture and to have access to the EEA market during thetransition period.

Pre-registration should be seen only as adeclaration of the intention to register a substance,it does not oblige a manufacturer or importer toactually proceed to register the substance.

The only obligation triggered by pre-registration isthe duty to participate in the Substance InformationExchange Forum (SIEF) of the pre-registeredsubstance and the substances that the pre-registrant has indicated as being similar to the pre-registered substance for the purpose of

DisclaimerThe author reserves the right not to be held responsible for the topicality, correctness, completeness or quality of theinformation provided. Liability claims regarding damage caused by the use of any information provided, including any kind of information that is incomplete or incorrect, will therefore be rejected.

REACH pre-registration requirements 3

read-across and application of (Q)SAR (QuantitativeStructure-Activity Relationships).

This will, however, generate a certain workload dueto the duties of SIEF members, which are:

• responding to requests for information of other SIEF members

• requesting missing information from other SIEF participants

• providing other SIEF participants with existing studies at their request

• collectively identifying the need for further studies to meet the registration requirements

• making arrangements to perform the identified studies

• agreeing on classification and labelling where there is a disagreement between potential registrants.

It is important therefore to consider carefully theworkload that the participation to SIEF willgenerate, especially if intending to pre-register asubstance for strategic reasons or when identifyingsubstances considered to be similar for thepurpose of read-across.

Figure 1: Overview of registration and pre-registration timelines

1 June 2007

Entryinto

forc

e

1 June 2008

Entryinto

operatio

n

1 Decem

ber 2008

30 Novem

ber 2010

31 May 2013

31 May 2018

Set-up of Europe Chemicals Agency

Pre-registration

Registration of:≥ 1 tonne/year CMRs≥ 100 tonnes/year very toxic to the aquatic environment≥ 1000 tonnes/year

≥ 100 tonnes/year

≥ 1 tonne/year

New substances

2. When to pre-register?

The period for pre-registration began on 1 June2008 and will end on 1 December 2008. Failure tomeet the deadline for pre-registration will meanthat a company loses the benefit of the extendedregistration deadline and will have to register thesubstance before it can continue manufacturing or importing of that substance.

An exemption to the general rule exists forsubstances that are manufactured or used in the EEA or imported within the EEA market (inquantities exceeding 1 tonne per year) for the first time after 1 December 2008. In this case, a company will still be able to benefit from thetransition measures on condition that therequested information for pre-registration issubmitted within six months of the firstmanufacture, use or import of the substance, and at least twelve months before the relevantregistration deadline (e.g. 30 November 2009 for substance in the first tonnage band).

4. What can be pre-registered?

The following substances can be (pre-)registered:

• Substances on their own (e.g. zinc or zinc oxide) or in preparations (e.g. nickel in ferronickel), including chemically modified intermediates (e.g. copper matte), which are imported or manufactured in quantities of 1 tonne or more per year.

• Substances in articles which are intended to be released from the articles and are present in quantities of 1 tonne or more per year.

Manufacturers or importers of substances inquantities of less than 1 tonne per year who foreseeincreasing their manufacturing/import capacities toquantities exceeding the 1 tonne per year thresholdmay opt to pre-register and hence to be involved inthe SIEF discussion for strategic reasons.

Only substances on their own or contained inpreparations or in articles (that are intended to be released under reasonable foreseeable conditionsof use) manufactured from primary sources arerequired to be pre-registered and registered underREACH, except if an exemption applies.

Substances resulting from a recovery processmight be able to benefit from the exemption fromregistration in Article 2.7(d). However, due to thecurrent lack of clarity on the practical applicationof this Article, the application of this exemption isuncertain. Therefore, manufacturers and importersof substances and alloys from recovered materialsare advised to pre-register these substances andsubstances in alloys in order to ensure their accessto the EEA market during the transition period(comprised between the pre-registration and theregistration deadlines).

REACH pre-registration requirements 4

3. Who can pre-register a substance?

Each natural and legal person who is required toregister a phase-in substance after 1 June 2008may pre-register that substance. These personsinclude:

• EEA manufacturers or importers of substances, either on their own or in preparations in quantities totalling 1 tonne or more per year2,including intermediates.

• EEA importers of articles containing substances which are released under normal and reasonable conditions of use and are present in quantities totalling 1 tonne or more per year.

• An ‘Only Representative’: As non-EEA manufacturers cannot directly pre-register or register substances, substances in a preparation or substances in articles, they may appoint an ‘Only Representative (OR)’ to take over the duties of their customers (importers)3.

It is important to note that for EEA manufacturers,both the pre-registration and the registration underREACH must be prepared and performed on thebasis of one pre-registration per legal entity.

EEA manufacturers and importers (or an OR of anon-EU manufacturer) of substances, preparationsor articles including substances with an intendedrelease, may opt to pre-register a substance forpractical and/or strategic reasons if they are:

• currently manufacturing or importing in volumes of less than 1 tonne per year, but intend to increase this volume in the future; or

• currently not manufacturing or importing in the EEA, but intend to start doing so after 1 December 2008.

Alternatively in these cases, providing the correctconditions are met, one may still fall back on theexemption to the general rule on pre-registration ofphase-in substances as outlined in section 2.

REACH pre-registration requirements 5

5. What should not be pre-registered?

The following are out of the scope of REACH orexempted from registration and hence, from pre-registration:

• Minerals, ores and ore concentrates: REACH only recognises as ‘minerals, ores and ore concentrates’ those materials that have not been chemically modified. Manual, mechanical or gravitational processes, dissolution in water, flotation, extraction with water, steam distillation, drying, or extraction from air are not considered to constitute chemical modifications. Processes to remove impurities, but that leave the chemical structure of the remaining constituents unchanged, are also not considered to constitute chemical modification4.

• Substances resulting from a recovery process might benefit from exemption from registration under Article 2.7(d). However, due to the current lack of clarity on the practical application of this Article, the application of this exemption is uncertain. Manufacturers and importers of substances and alloys from recovered materials are therefore advised to pre-register these substances and substances in alloys in order to ensure their access to the EEA market during the transition period (between the pre-registration and the registration deadlines).

• Waste as defined in Directive 2006/12/EC

• preparations themselves

• articles themselves

• non-isolated intermediates5

• by-products, unless they are imported or placed on the market

• re-imported substances, are exempted (as outline in article 2.7(c)), if:

• the re-importer substance is the same; and

• the EU origin can be demonstrated via the availability of article 31 or 32 information

• substances used in medical products for medical or veterinary use

• substances used in food or feeding stuff

• substances under Customs supervision.

For an exhaustive list of full and partial exemptionsfrom the scope of the legislation we invite you toconsult Article 2 of the Regulation text.

6. What information needs to be provided?

As already indicated, the set of informationrequired for pre-registration is reasonablyrestricted:

• Contact information of the company;

• company name

• contact information (address, contact person, representative for the dossier)

• third party representative (name, address) (optional).

• Substance ID;

• EC (EINECS or ELINCS) number

• CAS number

• IUPAC name

• other names (common names, trade names, abbreviations, others).

• Envisaged tonnage band and deadline for registration.

• Names of similar substances (read-across, (Q)SARs, grouping).

• Interest in acting as SIEF facilitator (optional).

REACH pre-registration requirements 6

8. What are the consequences of failing topre-register?

No access to the marketMissing the pre-registration deadline for thesubstance, means loss of access to the EEAmarket: ‘no data, no market’, i.e. no registrationdossier, no manufacturing or import.

Should a non-EEA manufacturer intend tolegitimately market a substance in the EEA afterthe pre-registration deadline without having pre-registered, they need to consider that:

• Registration requirements apply from 1 June 2008 (even though the pre-registration deadline is 1 December 2008).

• Non-EEA Manufacturers or EEA importers will have to perform the registration before the import of the substance can be continued beyond 1 June 2008.

• One may have to interrupt manufacture, marketing and use of the substance from 1 June 2008 up until 3 weeks after completion of registration, subject to:

• the inquiry process to check if there are producers that want to register the same substance. The required data are outlined in Article 26 § 1

• submission of testing proposals for vertebrate animal studies

• submission of Registration dossier

• completeness of the Registration being checked by the Agency.

If pre-registration is not completed and themarketing or use of the substance continues, thisputs the producer/importer and clients at risk, asthe marketing of the substance will be consideredillegal and subject to measures under developmentat Member State level.

Even if not pre-registering, entities are still boundto data sharing and joint submission of the coredata set for the substance.

7. How to proceed with pre-registration?

Pre-registration can be done in two ways:

1. On-line pre-registrationThe information is submitted directly on theREACH-IT Internet space. This online tool is mainly designed for individual submissions for pre-registration and notification dossiers.

2. Offline pre-registrationThe information is compiled in a IUCLID 5 pre-registration file (IZ5 file format, through aplug-in software) or other offline tools (using thepre-defined XML format). Each file needs to beuploaded via the REACH-IT tool, ‘one-by-one’ or via a ‘bulk submission’ of several files. The latter is however only possible for substances that havean EC number.

This second solution could be the most appropriateas it allows the pre-registration file to later be usedas a starting point for the compilation of the finalregistration dossier.

REACH pre-registration requirements 7

9. Recommendations

In order to ensure timely and successful pre-registration and registration, and in order to correctly identify obligations under REACH,companies should:

• Prepare an inventory of all the substances they manufacture, use or import, including substances on their own, in preparations or in articles, and substances that are considered intermediates under REACH. By-products (such as, slags and drosses) and recovered materials should also be included in the inventory as they may in the future no longer be considered as waste and therefore fall within the scope of REACH.

• Calculate the tonnage bands that are currently manufactured or imported per legal entity. The calculation of this annual average volume, may be based either on the three last consecutive years of manufacturing and/or import, or if one expects to increase production the future annual volume can also be taken into account to calculate the average.

• For non-EEA-manufacturers it will be critical to decide as soon as possible on the strategy to follow, i.e. to identify and appoint a suitable ‘Only Representative’ or to leave it to the importers to register the substance.

• How one prepares the pre-registration data ahead of the actual pre-registration largely depends on how one intends to perform the pre-registration. There are two major options:

• on-line: in this case one needs to have the required information at hand in whatever form so that it can be entered manually and substance by substance; or

• off-line: Here, one can prepare the electronic file in XML format, either via the use of the IUCLID 5 pre-registration plug-in or with any other tool that uses the available XML template. This method has the advantage that one can prepare the file in advance and that one can submit the pre-registration for single or multiple substances in one go.

• Contact and join a Consortium to facilitate pre-registration and ensure structured formation of a SIEF.

• Consult the REACH Metals Gateway (www.reach-metals.eu) for further information on consortia as well as the latest information in respect of the implementation of REACH.

End Notes1 Some materials that companies have traditionally referred to as ‘ores’ or ‘concentrates’ may not be legally recognised as such under REACH.2 Or those intending to manufacture/market a substance above 1 tonne per year in the future.3 An OR can be any natural or legal person located in the EEA and shall have a sufficient background in the practical handling of substances.4 The definition of ‘not chemically modified’ is critical and poses some interpretation challenges. See www.reach-metals.eu for more details.5 ‘Non-Isolated’ means not intentionally removed from the process equipment.

ICMM35/38 Portman SquareLondon W1H 6LRUnited Kingdom

Phone: +44 (0) 20 7467 5080Fax: +44 (0) 20 7467 5081Email: info@icmm.com

www.icmm.com

EurometauxEurometaux constitutes the interface between theEuropean non-ferrous metals industry and the Europeanauthorities and international or intergovernmental bodies.It is committed to establishing dialogue with the latter inorder to ensure early consultation in all fields of policy andlegislation that may affect industry and to asserting thesector’s views and positions in this respect. It asserts thecontribution of the European industry and its products tosustainable development, as well as this industry’s viewsand positions, whenever the opportunity to do so arisesacross all sectors of society.

www.eurometaux.org

ICMMThe International Council on Mining and Metals (ICMM) is a CEO-led industry group that addresses key prioritiesand emerging issues within the industry. It seeks to play a leading role within the industry in promoting goodpractice and improved performance, and encouragesgreater consistency of approach nationally and acrossdifferent commodities through its association membersand member companies. ICMM’s vision is for a respectedmining and metals industry that is widely recognized asessential for society and as a key contributor tosustainable development.

For further information on industry initiatives on hazardand risk assessment, including MERAG and HERAG, visit:www.metalsriskassessment.org