Seminar on EU Chemical Regulatory System

Seminar on EU Chemical Regulatory System REACH

17th July 2012

REACH

2012717

Understanding REACHREACH is a regulation of the European Union (EU) and applies to 27 EU Members States, and REACH also apply to Norway, Iceland and Liechestein,REACH stands for Registration, Evaluation, Authorisation and Restriction of ChemicalsIt entered into force on 1 June 2007.

REACHREACH European Union EU27EUREACH Registration, Evaluation, Authorisation and Restriction of Chemicals200761

AIMSTo provide a high level of protection of human health and the environment from the use of chemicals.To make the people who place chemicals on the market (manufacturers and importers responsible for understanding and managing the risks associated with their use.)To allow the free movement of substances on the EU market.To enhance innovation in and the competitiveness of the EU chemicals industry.To promote the use of alternative methods for the assessment of the hazardous properties of substances e.g. quantitative structure-activity relationships (QSAR) and read across.

( EUEUQSAR

Understanding REACHIt placed the burden of proof of safety for chemical on the shoulders of industry and no longer on government authorities.To comply with the regulation, companies must identify and manage the risks linked to the substances they manufacture and market in the EU.They have to demostrate how substance can be safely used and they communicate the risk management measures to the users.If the risk cannot be managed, authorities can restrict the use of substance. In the log run, the most hazardous substances should be substituted with less dangerous ones.

REACHEU

REACH ImpactLeading regulatory drivers (Chemical Watch survey 2012)

REACH (2012)

REACH ImpactIntroduction/expansion of REACH-like regulations in many other countriesThe registration deadline for Turkeys chemicals notification regulation drove a lot of activity in the first part of 2011.China revised its registration scheme to create Decree 7 on the Measures on Environmental Administration of New Chemical SubstancesTaiwan pursued its new scheme for existing chemical substance nomination (ECN) and plans for new chemical notification (NCN)

REACHREACH20117(ECN) (NCN)

REACH ImpactSerbia also enacted a chemicals management and control system in 2011Malaysia now has an Environmentally Hazardous Substances Notification and Registration (EHSNR) SchemeJapanese REACH "Chemical Substance Control Law" (CSCL) has been amended which was officially published in May 2009.Korean REACH "Toxic Chemicals Control Act" (TCCA)

REACH2011(EHSNR)REACH (CSCL)20095 REACH " (TCCA)

REACH ImpactIn the US, TSCA reform was held up in 2011 due to political gridlock, and any further movement will not be likely in 2012 due to the fact that 2012 is an election yearthe new Chemical Data Reporting Rule (formerly the Inventory Update rule), which determines what and how exposure-related information on chemicals is collected, was adopted with implementation beginning in 2012

REACH, 2011TSCA 20122012 (), 2012

REACH Impact

It will be difficult that some REACH do not REACH you.

We can take two options,A passive option, where we think that in a difficult path, even a straw is a heavy burden ...OrAn active option, and try to anticipate a new global concept of management of chemicals.

REACH

REACH

REACH Impact

In the following slides we will introduce definitions and concepts that are necessary to understand the requirements of REACHSubstances, mixtures and articles.Manufacturers, Importer, Down

REACH

REACH

Substances, mixtures and articlesSUBSTANCES:

It means a chemical element and its compounds.It includes bothsubstances obtained by a manufacturing process (for example formaldehyde or methanol) andsubstances in their natural state.It also includes its additives and impurities where these are part of its manufacturing process.Excludes any solvent which can be separated without affecting the stability of the substance

Substances, mixtures and articlesMIXTURES:

Mixture or solution composed of two or more substances.Examples:Paints,VarnishesInks.REACH obligations apply individually to each subtances.

:

:REACH

Substances, mixtures and articlesMIXTURES (2):

Alloys: Specials mixtures.The alloy is not subject to registration, the alloying elements (e.g. metals) have to be registered.Constituents which are not intentionally added to the alloy should be considered as impurities

(2):

: .

Substances, mixtures and articlesARTICLES:

Is an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical compositionExamples: textiles, electronic chips, furniture, books, toys, kitchen equipment).

Substances, mixtures and articlesARTICLES (2):

An individual substance in an article is subject to the registration obligations in case it is present in the article in quantities over one tonne per year and the substance is intended to be released under normal or reasonably foreseeable conditions of use.

Substances, mixtures and articlesPACKAGINGSubstances, mixtures and articles can be contained inside of packaging, such as a carton, a plastic wrapping or a tin can. The packaging does not belong to the substance, mixture or article being packaged and is therefore to be considered as a separate article under REACH. Producers, importers and suppliers of packaging or of packaged substances, mixtures or articles have to fulfil the same requirements for that packaging as for any other article. Packaging with different functions needs to be considered separately (e.g. if an article is directly wrapped in plastic and then packed in a cardboard box, the plastic and the cardboard box should be considered separate articles).

REACH (

Substances, mixtures and articlesIdentification process (example) (1)If you can unambiguously conclude that the shape, surface or design of the object is more relevant for the function than its chemical composition, the object is an article. If the shape, surface or design is of equal or less importance than the chemical composition, it is a substance or mixture.A wax crayon consists of paraffin wax and pigments and is used for colouring and drawing on paper. As its shape/surface/design are not more relevant for the function of the crayon (to bring pigment to paper) than its chemical composition, it is to be regarded as a mixture.

() (1)//

Substances, mixtures and articlesIdentification process (example) (2)If it is not possible to unambiguously conclude whether the object fulfils the REACH definition of an article or not, a deeper assessment is needed.if the object, which may be constructed in a very simple or highly sophisticated manner, contains a substance or mixture that can be physically separated from the object, lets go to answer some question.

() (2)REACH

Substances, mixtures and articlesIdentification process (example) (3)If you can answer these questions predominantly with yes (i.e. 2 of 3) rather than no, then the object should be regarded as a combination of an article (functioning as a container or a carrier material) and a substance/mixture.Question a: If the substance/mixture were to be removed or separated from the object and used independently from it, would the substance/mixture still be capable in principle (though perhaps without convenience or sophistication) of carrying out the function defined under step 1?Question b: Does the object act mainly (i.e. according to the function defined under step 1) as a container or carrier for release or controlled delivery of the substance/mixture or its reaction products?Question c: Is the substance/mixture consumed (i.e. used up e.g. due to a chemical or physical modification) or eliminated (i.e. released from the object) during the use phase of the object, thereby rendering the object useless and leading to the end of its service life?

(3) (32)/ a: //1 b: 1// c: /

Substances, mixtures and articlesPrinter cartridgeAnswering the above indicative questions: a) if the toner/ink was moved from the cartridge, it would still be possible to bring it to paper, although with a loss of quality and convenience; b) the function of the cartridge is to hold the toner/ink in place inside a printer and it controls the speed and mode of release; c) the cartridge is disposed of without the toner/ink, which is consumed during the service life of the cartridge. The answers to the questions allow the conclusion that a printer cartridge is a combination of an article (functioning as container) and a substance/mixture.Importers and suppliers of a combination of an article and a substance/mixture therefore have to separately check if obligations for the article apply and if obligations for the substance/mixture apply.

: a) /b) / c) / ()/.//

Substances, mixtures and articlesIdentification process (example) (5)

If you can answer these questions with yes rather than no, then the function of the object is likely to be determined rather by the physical properties shape, surface and design, than by the chemical composition. The object is then regarded as an article with an integral substance/mixture (i.e. the substance/mixture forms an integral part of the article))Question a: If the substance/mixture were to be removed or separated from the object, would the object be unable to fulfil its intended purpose?Question b: Is the main purpose of the object other than to deliver the substance/mixture or its reaction products?Question c: Is the object normally discarded with the substance/mixture at the end of its service life, i.e. at disposal?

(5)

//)) a: / b:/ c: /

Substances, mixtures and articlesExample: ThermometerAnswering the above questions: a) the empty thermometer would fail to show the temperature; thus the object would no longer be useful; b) the main function of the thermometer is to show the temperature, this is not a delivery of a substance or mixture;c) the thermometer is normally disposed of together with its chemical content.So answering these questions leads to the conclusion that a thermometer is an article and the liquid within an integral part of it.

: : a) ; b) ;c)

Substances, mixtures and articlesMore help:

Guidance for articleshttp://www.echa.europa.eu/documents/10162/13632/articles_en.pdf

:

http://www.echa.europa.eu/documents/10162/13632/articles_en.pdf

Substances, mixtures and articlesThe registration obligations apply therefore to the individual substances themselves, independently of whether they are on their own, in a mixture or in an article. In other words, only substances have to be registered under REACH, mixtures or articles do not.

A small recommendation: You should make an inventory of substances, mixtures and / or articles that you manufacture or use in your business.

REACH

: /

Substance IdentityUnambiguous substance identification is a pre-requisite to most of the REACH processes.The correct identification of a substance will enable, for example:The sharing of information by potential registrants and data holders to prevent the duplication of testing on animals and unnecessary costsThe assessment of the applicability of test data across companies who registered the same substance, the assessment of read-across proposals (categorisation approach) or the use of non test informationThe assessment if a substance is included in the Authorisation List, the list of restrictions or if its classification and labelling has been harmonised

Substance IdentityPhase-in substances:Substances listed in the European INventory of Existing Commercial chemical Substances (EINECS);Substances that have been manufactured in the EU (including accession countries on 1 January 2007) but have not been placed on the EU market after 1 June 1992;Substances that qualify as a so-called no-longer polymer).

:( EINECS)EU (200711)199261;

Substance IdentityNon-Phase-in substances:All substances that do not fulfil any of the criteria for phase-in substances are considered as non-phase-in substances. Normally, non-phase-in substances have not been manufactured, placed on the market or used in the EU before 1 June 2008, unless they were notified under Directive 67/548/EEC.Potential manufacturers and importers of non-phase-in substances have to submit an inquiry to ECHA and subsequently register the substance in accordance with REACH before they can manufacture or import the substance.

:200861 67/548/EEC.ECHAREACH

ESIS: European Chemical Substances Information Systemhttp://esis.jrc.ec.europa.eu/

ESIS: http://esis.jrc.ec.europa.eu/

Substance IdentitySubstances of well defined chemical compositionMonoconstituent substanceAs a general rule, a substance, defined by its composition, in which one main constituent is present to at least 80% (w/w).Multi-constituent substanceAs a general rule, a substance, defined by its composition, in which more than one main constituent is present in a concentration 10% (w/w) and < 80% (w/w).Impurities and Additives.impurities > 1%, or classified as dangerous, to be specified

80% w/w.10% (w/w) < 80% (w/w) > 1%,

Substance IdentityUVCB SUBSTANCESSubstances of Unknown or Variable composition, Complex reaction products or Biological materialsThe number of constituents is relatively large and/orThe composition is, to a significant part, unknown and/orThe variability of composition is relatively large or poorly predictable.UVCB substances require other types of information for their identification, in addition to what is known about their chemical composition

UVCB //UVCB

Substance IdentityMore HelpGuidance for identification and naming of substances under REACH http://echa.europa.eu/documents/10162/13643/substance_id_en.pdfGuidance for monomers and polymershttp://www.echa.europa.eu/documents/10162/13632/polymers_en.pdf

Guidance for identification and naming of substances under REACH http://echa.europa.eu/documents/10162/13643/_id_en.pdfhttp://www.echa.europa.eu/documents/10162/13632/polymers_en.pdf

More helphttp://echa.europa.eu/web/guest/information-on-chemicals/registered-substances

http://echa.europa.eu/web/guest/information-on-chemicals/registered-substances

More help

More helpSubstances identified by industry to be registered by 31 May 2013.http://echa.europa.eu/information-on-chemicals/registered-substances/identified-substances-for-registration-in-2013Substances identified but not registered (Data as of 15th September 2011)http://echa.europa.eu/information-on-chemicals/registered-substances/identified-substances-for-registration-in-2010

20135http://echa.europa.eu/information-on-chemicals/registered-substances/identified-substances-for-registration-in-2013 (2011915)http://echa.europa.eu/information-on-chemicals/registered-substances/identified-substances-for-registration-in-2010

Roles under REACHIt is very important that companies correctly identify their role or roles in the supply chain for each substance they handle

Roles under REACHMANUFACTURER (M)

- Any natural o legal person established within the EU who manufactures a substance within the EU.

MANUFACTURING

- Production or extraction of substances in the natural state

REACH (M)

- EU

-

Roles under REACHIMPORTER (I):

- Any natural o legal person established within the EU who is responsible for import

Import

The physical introduction into the customs territory of the EU.

Placing on the market

Supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market

REACH(I):

- EU

EU

Roles under REACHONLY REPRESENTATIVE (OR):

Any natural o legal person established within the EU and appointed by a manufacturer, formulator or producer of an article established outside the EU to fulfil the obligations of importers.

REACH(OR):

EUEU

Roles under REACHDOWNSTREAM USER (DU):

Any natural o legal person established within the EU, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities.

Use:

Any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of any article or any other utilisation

REACH(DU):

EU

:

Different roles and responsibilities for industryA REACH navigator tool has been developed by the Commission to help the users identifying their obligations under REACH. It can be found on:http://echa.europa.leu/reach_en.htm

Features:Interactive tool on the Agency websiteSequence of questions (supported by guidance) to be answered by the userThe outcome is a list of obligations for the userEach of the obligations will be linked to guidance (RIP projects) describing how to fulfil the users obligations

REACHhttp://echa.europa.leu/reach_en.htm

: ()(REACH)

RegistrationThe obligation to register a substance applies only to certain actors established in the EU.

EU manufacturers and importers of substances on their own or in mixtures in quantities of one tonne or more per year.EU producers and importers of articles in case that the article contains a substance in quantities over 1 tonne per year and the substance is intended to be released under normal or reasonably foreseeable conditions of useOnly representatives established in the EU and appointed by a manufacturer, formulator or article producer established outside the EU to fulfil the registration obligations of importers

EU

EUEUEU

When registration is neededA manufacturer of a substance who uses the manufactured substance himself has a duty to register each substance manufactured in quantities of 1 tonne or more per year, unless exemptions apply, and will have to include information on his own use(s) and any identified uses of his customers.

An importer of a mixture has to register those substances which are present in the imported mixture in quantities of 1 tonne or more per year, unless exemptions apply. He will have to include information in his registration on the identified use(s) of the substance(s) in the mixture. There is no obligation for importers of mixtures to register the mixtures as such; indeed mixtures cannot be registered. his registration

When registration is not neededAny user of substances not manufactured or imported by himself, is a downstream user and has no obligation to register these substances.An importer of a substance, a mixture or an article, who is importing from a non-EU company who has appointed an only representative will be considered as a downstream user and therefore does not need to register.A manufacturer or importer of a substance which is exempted from registration under REACH has no obligation to register that substance.

EUREACH

Legal personality and boundaries.Only a natural or legal person established in the EU can be a registrant. REACH-IT and IUCLID use the term legal entity to refer to such a natural or legal person having rights and obligations under REACH.

Customs boundaries for manufacturing and import REACH applies to the European Economic Area (EEA), i.e. the 27 EU Member States and Iceland, Liechtenstein and Norway. This means that imports from Iceland, Liechtenstein and Norway are not considered imports for the purposes of REACH

EUREACH-ITIUCLDREACH

REACH(EEA), 27EUREACH

Who is responsible for the registration in case of Manufacturing?the registration should be made by the legal entity who undertakes the process of manufacturing.The registration obligation also applies in the case that the substance is not marketed in the EU but exported outside the EU after manufacturing. toll manufacturing?the legal entity that manufactures the substance on behalf of the third party is to be considered a manufacturer for the purposes of REACH and is required to register the substance he manufactures.

?EUEU ?REACH

Who is responsible for the registration in case of import?the registration should be made by the legal entity established in the EU who is responsible for the import. The responsibility for import depends on many factors such as who orders, who pays, who is dealing with the customs formalities, but this might not be conclusive on its own.Examples:A sales agency established in the EU and acting as an intermediary, i.e. transmitting an order from a buyer to a non-EU supplier (and being paid for that service). The sales agency is not responsible for the physical introduction of the goods. In many instances it will be the ultimate receiver of the goods (the consignee) who is the legal entity that is responsible for the import

?EU:EUEU

Who is responsible for the registration in case of

Only representative of a non-EU manufacturerUnder REACH, a natural or legal person established outside the EU, who manufactures a substance, formulates a mixture or produces an article can appoint an only representative to carry out the required registration of the substance that is imported (as such, in a mixture or in an article) into the EU.Non-EU distributors are not mentioned in Article 8(1) and can therefore not appoint an only representative.

EUREACH,EUEUEU 8(1)

Only representative of a non-EU manufacturerAn only representative is a legal entity established in the EU which has sufficient background in the practical handling of substances and the information related to them to be able to fulfil the obligations of importers.It should be noted that an only representative is not the same as a third party representativeIt is neither necessary nor advisable for an only representative to appoint a third party representative because an only representative is not obliged to disclose to the other participants in the data sharing process the identity of the non-EU manufacturer he is representing.

EUEUEU

Only representative of a non-EU manufacturerThe non-EU manufacturer needs to inform all the EU importers in the same supply chain that he has appointed an only representative to conduct the registration. A non-EU manufacturer can only appoint one only representative per substance. The only representatives registration should clearly specify which quantity of the imported substance it covers. The only representative can represent one or several non-EU manufacturers.The only representative will have to submit separate registrations for each of the companies he is representing

EUEUEU EU EU

Only representative of a non-EU manufacturer

What to register?Registration is required for all substances manufactured or imported in quantities of one tonne or more per year per manufacturer or importer unless they are exempted from the scope of registration. The registration requirement applies to all substances irrespective of whether they are hazardous or notFor all registrations, a registration dossier has to be prepared and submitted electronically to ECHA.

What is ECHA?European Chemicals AgencyECHA was founded in 2007 and is based in Helsinki, Finland. It is a modern, science-driven organisation which has grown rapidly to become one of the largest EU agencies.500 staff from 27 European countries.

Working for the safe use of chemicals

echa.europa.eu

ECHA?ECHA 2007EU27500

echa.europa.eu

ExemptionsSubstances exempted from the REACH Regulation.Radioactive substancesSubstances under customs supervisionSubstances used in the interest of defence and covered by national exemptions.WasteNon-isolated intermediates.Transported substances.

ExemptionsSubstances exempted from registration.Food or feedingstuffsMedicinal productsSubstances included in Annex IV of the REACH Regulation.Substances covered by Annex V of the REACH RegulationRecovered substance already registered.Re-imported substance.PolymersSubstances used for the purpose of research and development

REACHIVREACHV

ExemptionsSubstances regarded as registered.Substances for use in biocidal products.Substances for use in plant protection productsNotified substances according to Directive 67/548/EEC.European Inventory of Existing Commercial Chemical Substances (EINECS) contains, in principle, all substances on the Community market on 18 September 1981. European List of Notified Chemical Substances (ELINCS). European List of Notified Chemical Substances (ELINCS).

67/548/EEC (EINECS) 1981918 (ELINCS). European List of Notified Chemical s (ELINCS).

Exemptions Isolated intermediates.On-site isolated intermediateTransported isolated intermediatesA manufacturer or importer of an isolate intermediate in quantities of one tonne or more per year is required to register his substance under REACH.He may benefit from reduced registration requirements provided the manufacture and use of the substance takes place under strictly controlled conditions.

Volume The registration requirement is tightly bound to the volume of the substance manufactured or imported (or present in an article, if applicable).The volume of the substance will also determine the information to be submitted in the registration dossier. REACH defines four tonnage bands:1 to

REACH :1

Volume If certain exemptions to registration apply (such as in food or medicinal products or for PPORD purposes) the potential registrant does not need to include those quantities in his calculation to determine the volume he has to register.In the case that the same registrant manufactures and/or imports the same substance at different sites which belong to the same legal entity, then the volume of the substance to be registered is the total volume of the substance manufactured and/or imported at the different sites, because the sites are not separate legal entities

Volume If a substance is imported in several mixtures, the volume of the substance in each mixture will have to be agregated.if a substance is imported in several articles from which it is intended to be released, the potential registrant needs to sum up all quantities of the substance present in those articles.he needs to count only those articles from which the substance is intended to be released. Whenever a substance is intended to be released from an article, the total volume present in that article needs to be counted and not only the volume intended to be released

Registration deadlinesPhase-in substancesThere is a special transitional regime for substances which, under certain conditions, were already manufactured or placed on the market before REACH's entry into force. Companies can benefit from the transitional regime if they pre-registered their substances by 1 December 2008.The deadlines set for the registration of phase-in substances have been based on the tonnage manufactured or imported per manufacturer or importer or producer of articles

REACH2008121

Registration deadlinesCalculation of the tonnes per year for the registration of phase in-substancesIn the case of a phase-in substance that has been imported or manufactured for at least three consecutive years, the tonnes per year shall be calculated on the basis of the average tonnes manufactured or imported in the three preceding calendar years.If the substance has not been manufactured or imported for three consecutive years then the tonnes manufactured or imported in a calendar year should be used.The highest tonnage per year (calculated as the average of the three preceding years or per calendar year, as applicable) manufactured or imported after 1 June 2007 will determine the deadline for registration

200761

Registration deadlinesNon-Phase-in substancesNon phase-in substances do not benefit from the transitional regime provided for phase-in substances and need to be registered before they can be manufactured, imported or placed on the market in the EU, unless they have already been notified under Directive 67/548/EEC. (The substance will in that case also appear on the European List of Notified Chemical Substances (ELINCS)).

EU 67/548/EECELINCS

Registration deadlinesCalculation of the tonnes per year for the registration of non phase-in substancesThe tonnes per year of a non-phase-in substance to be reported in a registration dossier is the estimated quantity in tonnes that is expected to be manufactured and/or imported in the calendar year (1 January - 31 December) of registration.

111231/

Registration deadlines

Registration deadlines - Example 1.A company, based on its manufacture projections, has determined that it should register a phase-in substance by the 31st May 2013 (as its manufacture volume is expected to be in the 100-1000 tonnes range).Each year the company needs to calculate its yearly tonnage as the average over the three preceding years, e.g. in 2007 it is the average over 2004-2006.The deadline for registration is based on the highest tonnage calculated starting in 2007.In case this tonnage reaches 1000 tonnes, the registration is then due before the 1st December 2010. If this happens in 2011 or 2012 the registration is due without delay..If the tonnage stays in the 100-1000 tonnage band, then the registration should be submitted by the 31st May 2013.

- 1.2013531100-100020072004-200620071000201012120112012100-10002013531

Registration deadlines - Example 2.The volume manufactured by Company V is 600 tonnes in 2007, 900 tonnes in 2008, 1400 tonnes in 2009 and 2000 tonnes in 2010. The 3 year-average tonnage in 2010 is 966 tonnes per year, but the 3 year-average tonnage in 2011 is 1433 tonnes per year. In this case company V will have to register the substance as soon as possible in 2011 as the registration deadline for the substances on 1000 tonnes or more per year has passed on 30 November 2010. The registration requirements should be based on the 2011 tonnage calculated as the average over 2008-2010, i.e. 1433 tonnes

- 2.V2007600200890020091400 20102000201096620111433V201110002010113020112008-20101433

Registration deadlines - Example 3.The volume manufactured by Company V is 900 tonnes in 2007, 0 tonnes in 2008, 1000 tonnes in 2009. As the substance has not been manufactured during three consecutive years then the calendar year tonnage should be used. In this case the 1000 tonnes threshold has been reached in 2010, meaning that a registration is due on 30 November 2010 at the Latest. The information requirements for the registration will be based on the 2010 tonnage, i.e. 1000 tonnes.

- 3.V20079002008020091000 201010002010113020101000

Registration deadlines Is it possible to pre-register a phase-in substance after 1 December 2008?You may pre-register after 1 December 2008 if you are:able to prove that you are established in the European Community and manufacturing or importing phase-in substances (on their own or in a preparation) for the first time after 1 December 2008 in quantities of 1 tonne or more per year; orable to prove that you are established in the European Community and producing or importing articles that contain substances intended to be released under normal and reasonably conditions of use for the first time after 1 December 2008. In addition, the substance needs to be present in those articles in quantities of 1 tonne or more per year

20081212008121200812120081211

Registration deadlines Therefore first-time manufacturers or importers have to submit their late pre-registration before 1 June 2017 if the tonnage threshold of the substance are 1-100 tonnes per year. Companies manufacturing or importing substances for which the first and second registration deadlines applied cannot benefit from the late pre-registration and need to go through an inquiry process before being entitled to manufacture or import in the European market

1-100201761

Registration deadlines Manufacturers and importers of substances below 1 tonne per year.Manufacturers and importers of phase-in substances or article producers and importers containing phase-in substances in quantities of less than 1 tonne per year do not need to (late) (pre-)register. However, they may decide to late pre-register based on their intention to manufacture or import the substance in quantities of 1 tonne or more in the future

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Seminar on EU Chemical Regulatory System