Q&As

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REACH

REACH Registration

Who has to register substances?

Only a natural or legal person established within the European Economic Area (EEA)/EU can be a registrant. Registration must take place when this person:

  1. manufactures a substance within the EU in quantities of 1 tonne or more per year;
  2. imports a substance into the EU of quantities of 1 tonne or more per year; or
  3. has been appointed as an only representative according to Article 8 of REACH (see FAQs on Only Representative of non-EU manufacturer).

The national law of each country provides the specific provisions concerning natural or legal personality and when such a natural or legal person is established in its territory.

A company not established within the EU does not have direct obligations under REACH. For obligations of a non-EU company, please see to FAQ 12.

In order to identify your obligations, please use the Navigator tool:
http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation/identify-your-obligations

This tool is designed to help companies in determining their obligations under REACH and find the appropriate guidance on how to fulfil them.

Vem ska sköta registreringen vid legotillverkning av ämnen?

En legotillverkare anses i regel vara ett företag som mot ekonomisk ersättning tillverkar ett ämne (som sådant, ingående i blandning eller i en vara) i sina egna tekniska utrymmen enligt anvisningar från en tredje part. Ämnet släpps i regel ut på marknaden av den tredje parten. Till exempel används den här konstruktionen för mellanled i produktionsprocessen som kräver sofistikerad utrustning (destillation, centrifugering osv.). Enligt Reachförordningen måste tillverkare av ämnen i mängder om 1 ton eller mer per år registrera dem. Legotillverkare betraktas i detta avseende som tillverkare och måste registrera ämnet.

Detta scenario diskuteras närmare i faktabladet ”Legotillverkare enligt Reach-förordningen” som finns på följande adress:
https://echa.europa.eu/documents/10162/13634/factsheet_toll_manufacturer_sv.pdf

In case of an international company, who is the registrant?

International companies sometimes have several daughter companies in the EEA/EU, often spread over several countries. If these subsidiaries of the parent company are separate legal entities from it, (a natural or legal person as defined under applicable national law), then each of those must determine if they qualify as registrant under REACH.Please see FAQ ID=27 on who has to register a substance.

Which substances have to be registered?
Registration is required for all substances:
- as defined in Article 3(1) of REACH;
- manufactured in or imported into the EU in quantities of 1 tonne or more per registrant per year;
- unless they are exempted from registration or regarded as being already registered, according to provisions in Articles 2, 9, 15 or 24 of the REACH Regulation;
- irrespective of whether they are classified as dangerous or not.
If you want to know whether you have to register a substance you should first consult section 2.2- 'What to register?' of the Guidance on registration. There you will also find information on substances exempted from registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.
In addition, the Navigator tool can help to clarify the registration obligations for your specific substance: http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation/identify-your-obligations.
Do I have to register alloys?
The REACH Regulation refers to alloys as "special mixtures" (Recital (31), Annex I (0.11.), as amended by Regulation (EC) No 1272/2008). Therefore, an alloy is to be treated in the same way as other mixtures under REACH, which means that the alloy as such is not subject to registration but the alloying elements (e.g. metals), irrespectively of the production process of the alloy are. However, components which are not important for the properties of the alloy should be considered as impurities (i.e. they are part of a substance in the mixture) and therefore need not be registered separately. Please note that intermetallic compounds are often wrongly regarded as alloys, although they have a well defined stoichiometry. Such substances are listed in EINECS (e.g. "aluminium, compound with iron (1:1)", "iron, compound with titanium (2:1)", etc.) and cannot be regarded as mixtures, therefore these intermetallic compounds have to be registered as such. This means that e.g. separate (pre-)registrations of the substances Al and Fe do not cover the substances "aluminium, compound with iron (1:1)" or "aluminium, compound with iron (1:3)". For each intermetallic compound with a different metal ratio a separate (pre-)registration is required.
Do I have to register a substance occurring in nature if I have to apply a process to extract this substance?
Substances occurring in nature are exempted from the duty to register in accordance with Article 2(7)(b) and Annex V, point 8 of REACH, as long as they are not chemically modified, not classified as dangerous in accordance with Directive 67/548/EEC, nor substances of very high concern, such as PBT or vPvB substances. If a process is applied to extract such a substance, it has to be verified whether the process applied is one of those listed in Article 3(39) of the REACH Regulation. If this is the case, the substance still qualifies as substance that occurs in nature that does not have to be registered.
The processes mentioned in Article 3(39) of REACH are manual, mechanical or gravitational processes, dissolution in water, flotation, extraction with water, steam distillation, heating solely to remove water and extraction from air. Please note that extraction with solvents other than water, like e.g. hexane or ethanol, are not covered by Article 3(39) of REACH. Substances which are extracted with these solvents do not qualify as a substance that occurs in nature and cannot be exempted from registration on the basis of Annex V, point 8 of REACH.
Lavender oil, for example, is extracted from flowers of certain species of lavender (which occur in nature) by means of steam distillation. The subsequent spontaneous separation of oil and water allows an easy isolation of the lavender oil. As this extraction process is mentioned in Article 3(39) of REACH, the lavender oil can be regarded as a substance that occurs in nature.
On the contrary, chrysanthemum oil, for example, which is extracted from chrysanthemum blossoms and leaves (which occur in nature) with a solvent mixture of water and ethanol (1:10), cannot be regarded as a substance that occurs in nature.
In general, it is important to remember that it is up to the manufacturer to assess the process applied and to determine if the definition of Article 3(39) of REACH is applicable or not.
Vad ingår i definitionen PPORD (produkt- och processinriktad forskning och utveckling)?
Enligt artikel 3.22 i Reach-förordningen definieras PPORD som ”vetenskaplig utveckling i samband med produktutveckling eller vidareutveckling av ett ämne – som sådant eller ingående i beredningar eller varor – varvid pilotanläggningar eller produktionsförsök används för att utveckla produktionsprocessen och/eller testa användningsområden för ämnet”. All vetenskaplig utveckling av ett ämne som består exempelvis av ett eller flera projekt för uppskalning eller förbättring av en produktionsprocess i en pilotanläggning eller vid fullskalig produktion, eller undersökning av användningsområdena för detta ämne, faller under definitionen för PPORD, oavsett vilka mängder som gäller.
För att främja innovation anger artikel 9 i Reach-förordningen att ämnen som sådana och i blandningar som tillverkas i gemenskapen eller importeras dit och ämnen som ingår i varor eller importeras i varor kan undantas från registreringsplikten under en femårsperiod om ändamålet är PPORD. För att undantas måste ett företag lämna in en PPORD-anmälan till Echa. Echa kan på begäran förlänga undantagsperioden med upp till ytterligare fem år, eller tio år för utveckling av läkemedel (humanläkemedel eller veterinärmedicinska läkemedel) liksom för ämnen som inte släppts ut på marknaden. Mer information finns i Vägledning om vetenskaplig forskning och utveckling och om produkt- och processorienterad forskning och utveckling (PPORD): http://echa.europa.eu/guidance-documents/guidance-on-reach.
Have PORD exemptions under Directive 67/548/EEC been transferred into REACH?

National Process Orientated Research and Development (PORD) exemptions for the notification of substances under Directive 67/548/EEC are no longer valid under REACH since 1 June 2008, because there are no such notifications under REACH. Therefore, to benefit from the registration exemption, manufacturers or importers of substances or producers of articles wishing to continue their PORD activities need to submit a PPORD notification (REACH, Article 9). For guidance on how to prepare and submit a PPORD notification in practice, please consult the Data Submission Manual 1, available at:

http://www.echa.europa.eu/support/dossier-submission-tools/reach-it/data-submission-manuals

Does a potential registrant have to register a substance he is manufacturing or importing if this substance has previously been notified under Directive 67/548/EEC by another manufacturer or importer and is, thus, regarded as registered under the REACH Regulation?

Yes, a notification under Directive 67/548/EEC as amended by Directive 92/32/EEC is nominal so that only the notifier benefits from the provision that notified substances are being considered registered. Therefore, any other parties manufacturing or importing the substance in quantities of more than one tonne per year who have not notified this substance, must register it unless another exemption from the duty to register applies. More information on notified substances can be found in Article 24 (2) of the REACH Regulation and in Section 2.2.4.3- 'Notified substances according to Directive 67/548/EEC' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.

Will a registration under the REACH Regulation be required for substances that are manufactured within the EEA but exported 100% outside of the EEA?
Yes. Article 6 of the REACH Regulation requires a manufacturer of a substance in quantities of more than 1 tonne per year to submit a registration, irrespective of whether this substance will subsequently be exported outside of the EEA. Therefore, substances manufactured in the EEA above this limit that do not meet any of the criteria for exemption from registration in accordance with Article 2 of the REACH Regulation and which are subsequently exported to non-EEA countries must be registered. The rationale for this duty is that the exposure resulting from manufacture and any other activity before export could be relevant for workers and the environment in the EEA.
Do I have to register chemically surface treated substances?
The surface treatment of a substance is a "two dimensional" modification of macroscopic particles. A "two dimensional" modification means a chemical reaction between the functional groups only on the surface of a macroscopic particle with a substance which is called a surface treating substance.By this definition it becomes clear that this kind of modification means a reaction of only a minor part (surface) of a macroscopic particle with the surface treating substance, i.e. most of the macroscopic particle is unmodified.
Therefore a chemically surface treated substance cannot be regarded as a mixture nor be defined by the criteria of the Guidance for identification and naming of substances under REACH: http://echa.europa.eu/guidance-documents/guidance-on-reach.
With the same reasoning, a chemically surface treated substance could not be reported for EINECS nor be notified according to Directive 67/548/EEC because it was covered by the separate EINECS entries of both the basis substance (macroscopic particle) and the surface treating substance.Taking this decision up under REACH means a consequent continuation of former decisions. Using the same line of arguments, chemically surface treated substances should not be registered as such under REACH, but the following requirements should be fulfilled:
1. Registration of the basis substance (macroscopic particle)
2. Registration of the surface treating substance
3. Description of the use "surface treatment" in the registration dossier of the surface treating substance and in the registration dossier of the basis substance
4. Any specific hazards or risks of the surface treated substance should be appropriately covered by the classification and labelling and by the chemicals safety assessment and resulting exposure scenarios.
Do I have to register substances used in medicinal products?2
According to Article 2(5)(a) of the REACH Regulation substances used in medicinal products for human or veterinary use within the scope of the relevant EU legislation are exempted from the Registration Title of the REACH Regulation (Title II). More explanation is provided for in Section 2.2.3.2- 'Medicinal products' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.
Substances fulfilling the conditions of Article 2(5)(a) of the REACH Regulation are also exempt from the Titles on Downstream Users, Evaluation and Authorisation (Titles V, VI and VII of the Regulation).
Importantly, substances are exempted from these Titles only to the extent that they are used in medicinal products in accordance with Regulation 726/2004, Directive 2001/82 and Directive 2001/83. Quantities of the same substance used for other purposes are not exempted.
The exemption covers the manufacture (in the EU) of substances in medicinal products that are exported; and the manufacture (in the EU) of active substances within the scope of EU legislation on medicinal products that are exported. The exemption also applies to imports of substances in medicinal products and imports of active substances within the scope of the EU rules on medicinal products.
Intermediates that are not present in the medicinal product (as defined in Regulation 726/2004, Directive 2001/82 and Directive 2001/83) are not exempted from registration. 
May pre-registered substances that are manufactured or imported before the relevant registration deadline be placed on the market after this deadline without a registration?

REACH imposes registration obligations only on manufacturers or importers (and, in specific cases, on producers or importers of articles). The registration obligation does not apply to downstream users or distributors. Therefore, the registration obligation does not apply to you if you have:

  • manufactured or imported pre-registered substances before the registration deadline; and
  • completely ceased such activities and only used the substances and/or supplied them after that.

For example, importers for whom the last batch of the substance was imported on 31 May 2018, at the latest, may continue to use and/or supply that substance after the deadline without a registration, without time-limitation. Since the pre-registered substance has not been registered, there is no obligation to notify ECHA of the cessation of manufacture/import. Article 50(2) and (3) of the REACH Regulation does not apply to this situation.

If you have not ceased your activities before the registration deadline, you have an obligation to register the substance according to Article 6 of REACH.

If you are a downstream user (or any other actor down the supply chain) who is not subject to the registration obligation, you can continue to use, without time-limitation, and/or supply quantities of the substance that were manufactured or imported before the registration deadline.

For the obligations of a downstream user or distributor and whether they are obliged to check the registration status of the substances on their own or in a mixture, please see Q&A 155

Is a metal hydroxide manufactured from the metal oxide covered by the exemption from registration in Annex V, point 6 of the REACH Regulation?
According to Annex V, point 6 of the REACH Regulation hydrates of a substance or hydrated ions, formed by association of a substance with water are exempted from registration, provided that the substance (i.e. the anhydrous form) has been registered by its manufacturer or importer.
 
Hydrates of a substance are characterised by the fact that water molecules are linked by molecular interactions, in particular by hydrogen bonds, to other molecules or ions of the substance. For the purposes of Annex V, hydrates and water free forms (anhydrous) of compounds shall be regarded as the same substance (e.g. CuSO4.5H2O and CuSO4).
 
In contrast, a metal hydroxide (e.g. Ca(OH)2) and a metal oxide (e.g. CaO) cannot be regarded as the same substance as both substances have different structures, regardless of the manufacturing process. The formation of the hydroxide involves forming new covalent bonds, which is different from forming a hydrate which only involves weak intermolecular bonds. Therefore a metal hydroxide manufactured from the metal oxide is not covered by the exemption from registration in Annex V, point 6.
Are substances that are banned under Regulation (EC) No. 2037/2000 (on substances that deplete the ozone layer) subject to (pre-) registration?

Yes. Substances are not exempted from (pre-)registration on the grounds that they are within the scope of Regulation (EC) No. 2037/2000 on substances that deplete the ozone layer. FAQ ID=30 explains which substances have to be (pre-)registered.

Is a registrant required to update their registration dossier with a new analysis dataset each time the substance is imported from a new non-EU manufacturer?
There is no explicit legal obligation for registrants to update their registration dossier every time an import is made from a new non-EU source. However, according to Article 22(1)(b) of REACH, there is a legal obligation to update the composition of the substance as given in Section 2 of Annex VI. The registrant has to assess the sameness of the substance every time an import of the substance is made from a new source, according to Guidance for identification and naming of substances available on the ECHA website.
There are three possible outcomes of this assessment:
 
1. Registrants find that the substance has the same impurity profile as previous imports and is already registered by them. They do not have to update the registration dossier for the substance.
 
2. Registrants find that the substance has a different impurity profile from previous imports. They then have to update the relevant sections of the registration dossier (e.g. concentration ranges or changes in C&L) with the new composition of the substance.
When do I have to register my substance?

Information on the various aspects that need to be taken into account before registration is provided in Section 2.3- 'When to register?' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.

The REACH Regulation created a transition regime involving a pre-registration phase for the registration of substances (Section 2.3.1.1- 'Phase-in substances' of the Guidance on registration). Depending on its intrinsic properties and its tonnage, a pre-registered substance needed to be registered before either of the relevant previous deadlines in 2010 and 2013, or by the last one on 31 May 2018.

Substances that were not pre-registered must be registered before the manufacture or import can continue at an annual quantity of one tonne or more. Before the registration of such substances, the manufacturer or importer has to make an inquiry to ECHA regarding any previous registration for that substance.

Upon registration, the registrant may have to wait for three weeks after the registration dossier is submitted before starting or continuing the manufacture or import of the substance (Article 21 of the REACH Regulation).

Hur beräknar jag volymen?

Alla registranter måste beräkna vilken årsvolym som ska uppges i registreringsunderlaget. Årsvolymen beräknas som volym per tillverkare/importör per kalenderår, om inget annat anges. För infasningsämnen som har importerats eller tillverkats i minst tre år i rad beräknas volymerna utifrån den genomsnittliga tillverknings- eller importvolymen under de tre föregående kalenderåren (artikel 3.30 i Reach-förordningen). Detaljerad vägledning och praktiska exempel finns i avsnitt 2.2.6 ,"Beräkning av den mängd som ska registreras", i vägledningen om registrering: http://echa.europa.eu/guidance-documents/guidance-on-reach

 

Can I register for a tonnage band higher than the actual tonnage of the substance?

Yes. Companies are free to register a substance for a tonnage band which is above the actual tonnage of the substance. This is also reflected in Section 2.2.6.3- 'Calculation of the total volume' of the Guidance on registration http://echa.europa.eu/guidance-documents/guidance-on-reach.

This section clarifies that companies are free to register a substance for the intended tonnage band. A registration at a higher tonnage band will trigger a higher registration fee in accordance with Regulation (EC) No 340/2008. In addition, the technical dossier will need to comprise all the information required for the registered tonnage band. Practical advice on how to complete a IUCLID dossier is provided in the Manual: How to prepare registrations and PPORDS at: http://echa.europa.eu/manuals.

How do I register my substances and do I need IUCLID?

All registrations shall be submitted to ECHA. This shall be done using the REACH-IT Portal. For more information please visit the REACH-IT section of the ECHA website: http://echa.europa.eu/support/dossier-submission-tools/reach-it.

According to Article 111 of the REACH Regulation, registration dossiers have to be submitted in the format of IUCLID (International Uniform Chemical Information Database). IUCLID is a software tool for companies to store data on chemicals and prepare registration dossiers. Registrants are not obliged to use the IUCLID software, but they must submit their registration in the IUCLID format.

The IUCLID software is downloadable free of charge from the IUCLID website http://iuclid6.echa.europa.eu/home.

Vad kostar det att göra en registrering?

Registreringsavgiften för ett ämne beror på vilken mängd (volym) som ska registreras, företagets storlek och typen av inlämning. Dessutom gäller:

  •  Avgifterna är lägre för gemensamma inlämningar än för enskilda inlämningar. Detta gäller inte om du hoppar av  från en gemensam inlämning.
  •  Avgiften för små och medelstora företag är lägre i alla kategorier.
  •  En extra avgift tas ut om man begär konfidentialitet.

Ingen avgift tas ut för registreringar av ämnen i mängder mellan 1 och 10 ton per år om registreringen innehåller all information som krävs enligt bilaga VII, där grundkraven fastställs för ämnen som tillverkas eller importeras i mängder på minst 1 ton.
Alla bestämmelser hittar du i artikel 74 i Reach. Avgifterna har fastställts i kommissionens förordning om avgifter ((EG) nr 340/2008). Du hittar mer information i Reach-IT:s "Frågor och svar" om fakturering (under "Invoicing"):
http://echa.europa.eu/qa-display/-/qadisplay/5s1R/view/reach-it/invoicing.

Can a Non-EEA manufacturer of a substance register under REACH?
No. The obligation to register a substance applies only to actors established within the EEA. Thus, the registration of substances imported into the EEA on their own, in mixtures or, in certain cases, in articles will have to be done by the importer established in the EEA. This implies that each individual importer needs to register the substance. However, according to Article 8(1) of the REACH Regulation manufacturers of substances, formulators of mixtures or producers of articles established outside the EEA, can nominate an only representative established within the EEA to carry out the required registration. This will relieve the individual EEA importers within the supply chain of that non-EEA manufacturer from their registration obligations for these substances. They will be regarded as downstream users of this only representative. However, the registration obligation may still apply if the EEA-importers import the same substance from other non-EEA manufacturers.
 
More information on the only representative role can be found in Only Representative of non-EU manufacturer and in section 2.1.2.5-'Only representative of a "non-EU manufacturer"' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.
What are the options for an importer of a mixture when he is unable to obtain the relevant information from his supplier on the components of the mixture?
To fulfil his duties as a registrant an EEA-based importer of mixtures has to have information on the composition of the mixtures he imports into the EEA. This obligation already existed under the previous legislation as regards substances to be classified as dangerous. Under REACH, an importer needs to know at least the identity and percentage content of all substances in the mixtures he imports that could exceed the amount of one tonne/year.
 
If the non-EEA supplier is not willing or not able to provide the required information, the importer has the following options:
- identify the formulator of the mixture (if different from the supplier) and ask him directly for the required information,
- propose to the non-EEA formulator that he appoints an only representative in accordance with Article 8 of the REACH Regulation,
- establish the composition of the mixture by analytical means,
- find an alternative supplier who is prepared to provide all required information for the mixture.
Can a third party representative register?

No, under REACH, a third party representative cannot register. A third party representative can be appointed by a manufacturer, importer or downstream user for data sharing issues and discussions with other manufacturers, importers or, where relevant, downstream users. Unlike an only representative, a third party representative only plays a part in the negotiations between the (potential) registrants, while the appointing company remains responsible for complying with its registration obligations.

A company who notified a substance under Directive 67/548/EEC fails to claim its registration number for the notified substance. Is this substance still considered as registered? If this is the case and an inquiry is subsequently submitted for this substance by a potential registrant can this notifier be listed as the registrant?
In accordance with Article 24 of the REACH Regulation, ECHA assigns a registration number to each notification submitted under Directive 67/548/EEC and the substance is considered registered according to REACH. The owner of the notification needs to claim the registration number from ECHA via REACH-IT in order to have valid evidence of a registration for the previously notified substance.

If an inquiry for this substance is submitted to ECHA by a potential registrant, the contact details of the notifier are communicated to the potential registrant according to Article 26(3) of REACH. In this respect, claimed and non-claimed registration numbers are treated equally in REACH-IT.

A letter with contact details of the potential registrant will also be sent to the notifier. In the same letter ECHA will again remind the notifier to claim the registration number.
What are the duties of registrants that cease manufacture and import?
If a registration for a substance has been submitted, the obligations to update the registration (Article 22) and to keep information (Article 36) apply. This means that a registrant ceasing manufacture and import of this substance has to inform the Agency about the new total tonnage manufactured and imported (in this case zero t/a). Furthermore this registrant has to keep available all the information he required to carry out his duties under REACH for a period of at least 10 years after he last manufactured, imported, supplied or used the substance (as such or in a mixture). In this regard, the period of at least 10 years does not start if the registrant, who ceased manufacture and import, still supplies or uses the substance.
If I have already notified a substance under Directive 67/548/EEC, what do I have to do if I increase my tonnages?

Under REACH, substances notified in accordance with Directive 67/548/EEC (known as NONS: Notification of New Substances) are regarded as registered by the manufacturer, importer, or sole representative who submitted the notification. You, as owner of the notification, can claim a registration number from ECHA for the tonnage notified. For practical details please see the Questions and Answers on NONS:

http://echa.europa.eu/support/qas-support/qas.

If the quantity of the manufactured or imported substance which you have notified reaches the next tonnage threshold, (1, 10, 100 or 1000 tonnes/year), you need to update your registration without 'undue delay'. You do not need to stop your manufacturing/importing while your updated dossier is processed unless otherwise indicated by ECHA.

When updating your registration dossier you need to comply both with:

  • the information requirements of the new tonnage band; and
  • the information requirements from the lower tonnage bands.

For example, if you increase your tonnage to 10 tonnes/year or more, you need to submit the information required for 10 tonnes or more (Annex VIII), the chemical safety report; and also the information required for 1 tonnes or more (Annex VII).

In order to avoid unnecessary testing on vertebrate animals, you have to inform ECHA immediately of the additional information requirements for the new tonnage level by submitting an inquiry dossier. Upon receipt of this information, ECHA acts as in the inquiry process which is further described in the chapter 'Update of registration dossier for substances regarded as being registered under REACH' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach. ECHA should inform you of the names and addresses of the previous registrants and of any relevant study summaries already submitted by them in order to share existing data and to ensure that studies on vertebrate animals are not unnecessarily repeated.

Does the phrase "classified as [...] in accordance with Directive 67/548/EEC" in Article 23(1)(a) and (b) of the REACH Regulation refer only to substances listed with a harmonized classification in Annex I of this directive?
The wording of Article 23(1)(a) and (b) of the REACH Regulation "classified as [...] in accordance with Directive 67/548/EEC" refers to both, substances listed in Annex I with their harmonised classification and to self-classified substances.
 
It may be inferred from Articles 4 and 6 of Directive 67/548/EEC that substances shall be classified (by manufacturers/importers) according to the criteria in Annex VI of that Directive. In addition, Annex I of that Directive contains the list of substances classified by the Commission, following discussions in expert groups. As the Directive covers both situations, substances should therefore be considered as classified in accordance with Directive 67/548 not only when listed with their harmonised classification in Annex I, but as soon as they meet the criteria for classification set out in Annex VI of that Directive, i.e. also when self-classified by the registrant, should the substance not (yet) be listed in Annex I. Both situations should be considered as "classification in accordance with Directive 67/548/EEC".
 
This interpretation is borne out by the very spirit of REACH and in particular the aim and objective of the deadlines provided for in Article 23 of REACH. The aim of the earlier deadline for registration of substances with properties of very high concern is to gather earlier the necessary information on the substances, on their uses and for industry to develop and recommend appropriate risk management measures. Given the specific health and/or environmental concerns in this case the objective was not to defer the application of the REACH provisions for further years. To this end, the aim of the legislature in setting the earlier registration deadlines was clearly to cover both cases, as there is no difference in the protected public interest. Substances with non-harmonized classification are equally a ground for the same concern as substances with harmonised classification.
 
A consequence of this interpretation is that, as from 1 December 2010, as soon as a manufacturer or importer obtains evidence that his substance fulfils the classification criteria set out in Art. 23(1)(a) or (b) of REACH after that date, he will be obliged to register that substance immediately.
Does a registration of an isolated intermediate pursuant to Article 17(2) or Article 18(2) of REACH have to be updated due to a change of tonnage band?
A manufacturer or importer who has registered an isolated intermediate pursuant to Article 17(2) or Article 18(2) of REACH does in general not have to update this registration in case of a change of tonnage band. However, such a registration would have to be updated due to a change of tonnage band in two cases.
 
Case 1: Where the registration is for a transported isolated intermediate and the 1000 t/a threshold is reached, the registrant must update his registration dossier by submitting the information specified in Annex VII of the REACH Regulation, if not already included in the dossier.
 
Case 2: Where the registrant ceases manufacture and import of the isolated intermediate, he has the duties described in FAQ ID=54, which include an update of the registration.
I plan to manufacture/import a phase-in substance for the first time either less than 12 months before the relevant registration deadline or after it. When do I have to register this substance in each case?
The "no data, no market" principle set out in Article 5 of the REACH Regulation applies to all substances that are manufactured or imported in quantities of 1 t/a or more where they have not been registered or pre-registered. This means that a company planning to start manufacture or import of 1 t/a or more of a phase-in substance after the relevant registration deadline given in Article 23 of REACH needs to have validly registered the substance before starting this activity.
 
According to Article 28(6) of REACH a first-time manufacturer or importer of a substance may submit a late pre-registration within 6 months of the date of first manufacture or import in quantities of 1 t/a or more of that substance and no later than 12 months before the relevant registration deadline given in Article 23 of REACH. Therefore, a company planning to start manufacture or import of 1 t/a or more of a phase-in substance less than 12 months before the relevant registration deadline also needs to have validly registered the substance before starting this activity.
 
In both cases, prior to registration the company planning to start manufacture or import has to submit an inquiry according to Article 26 of REACH. Further information can be found in section 4.4- 'Substances subject to the inquiry process' of the Guidance on data sharing: http://echa.europa.eu/guidance-documents/guidance-on-reach
 
After the submission of the registration dossier it may take up to three weeks before ECHA informs the registrant whether his registration is complete or not. Manufacture or import of a substance cannot start before the end of this period and can only start once ECHA has informed the registrant that the registration is complete and a registration number has been assigned.
Are registration numbers assigned to active substances in biocidal products? Does ECHA disseminate any information on those substances?
REACH does not provide for the assignation of registration numbers to active substances in biocidal products. It is reminded that registration numbers are assigned exclusively for substances:
- where complete registration dossiers were submitted to ECHA by the registrant according to Article 20 of REACH;
- which were notified under Directive 67/548/EEC and the registration number was claimed by the notifier according to Article 24 of REACH.
 
Regarding the information on active substances in biocidal products, this is held by the European Commission, and certain information is publicly available via its website at http://ec.europa.eu/environment/biocides.
 
ECHA has access to the information necessary for data sharing purposes.
If a registrant decides to change its Third Party Representative (TPR) does it need to update the registration and is there a fee for this?

If a registrant changes its TPR, the new TPR will have to create a REACH-IT account (provided he does not yet have a REACH-IT account).

In case of a change of TPR, the following steps shall be taken by the registrant in order to update the details of its TPR:

To update a TPR in a pre-registration or a registration submission: Go to menu -> Search -> Reference numbers -> Input the number in the search criteria -> Click on the results -> Click on Edit under Third party representative -> Add the new TPR.

No fee is required if the TPR is updated in a registration dossier.

I am a potential registrant of a non-phase-in substance or phase-in substances that has not been pre-registered. I am already in contact with the Lead Registrant (LR). Do I still need to send an inquiry to ECHA?

Yes. You have to submit an inquiry to ECHA although you have established a contact with the lead registrant (LR) and therefore have access to the respective and most up to date data package.

The obligation to submit an inquiry serves to avoid unnecessary testing and in particular to reduce testing on vertebrate animals. In addition, it provides the potential registrants the advantage that ECHA has verified the identity of the substance foreseen for registration and puts them in contact with the correct previous registrants and inquirers. By contrast, it is up to the members of a SIEF themselves to verify that they register the same substance.

Further guidance can be found in the Questions and Answers documents on inquiry and substance identification available in the following web page:
http://echa.europa.eu/regulations/reach/substance-registration/inquiry

Who can benefit from the phase-in scheme?

Manufacturers and importers who have manufactured a substance in any of the current Member States of the EU at least once after 31 May 1992 (15 years before the entry into force of REACH) and never placed it on the EU market can benefit from the phase-in scheme. This benefit also applies if you were a manufacturer before the entry into force of REACH and became an importer after it.

For all other manufacturers and first time importers who did not manufacture the substance in the EU, the substance is considered as a non-phase-in substance.
 

I would like to cooperate with a company in another Member State by ‘chemical leasing'. Does this business model influence my registration obligations under REACH?
Business models such as ‘chemical leasing', where the purchase is based on the fulfilled functions performed by the chemical and where the value-based units, such as the number of painted articles, are the main basis for payment, or any other business models do not influence your registration obligations. 
 
It is still the manufacturer or the importer to the EU who is responsible for registering the relevant substances under REACH.
A phase-in substance was registered and manufactured on an ongoing basis in the tonnage range 1-10 t/a. What does the registrant need to do, if they reach a higher tonnage threshold?

A registrant needs to update their registration without undue delay as soon as the ‘annual or total quantities’ they manufacture or import reach the next tonnage band threshold, as required by Article 22(1)(c). As soon as the annual volume of a substance that has already been registered (regardless of its phase-in status before registration) reaches the next tonnage threshold, the manufacturer or importer has the duty to immediately inform ECHA of the additional data required, following Article 12(2).

Further information is available at: http://echa.europa.eu/support/registration/your-registration-obligations/do-i-reach-the-one-tonne-a-year-threshold

Behöver jag registrera intermediärer?

Om du är skyldig att registrera intermediärer beror på till vilken typ av intermediärer din intermediär hör enligt definitionen i artikel 3.15 i Reachförordningen.

  • Icke-isolerade intermediärer:

Vid användning av ett ämne som en icke-isolerad intermediär finns det inga skyldigheter enligt Reachförordningen.

  • Isolerade intermediärer som används på plats:

En tillverkare av isolerade intermediärer som används på plats i mängder på 1 ton eller mer per år måste registrera sina ämnen, om de inte är undantagna från registreringsplikten (se FAQ ID=30). Registranter av isolerade intermediärer som används på plats kan dock tillhandahålla reducerad registreringsinformation enligt artikel 17.2 i Reachförordningen, om de kan bekräfta att ämnet tillverkas och används under strängt kontrollerade förhållanden enligt beskrivningen i artikel 17.3 i Reach.

  • Isolerade intermediärer som transporteras:

En tillverkare eller importör av isolerade intermediärer som transporteras i mängder på 1 ton eller mer per år måste registrera sina ämnen, om de inte är undantagna från registreringsplikten. Registranter av isolerade intermediärer som transporteras kan dock tillhandahålla reducerad registreringsinformation enligt artikel 18.2 i Reachförordningen, om de kan styrka att ämnet tillverkas och/eller används under strängt kontrollerade förhållanden och om de bekräftar eller uppger att de har fått bekräftelse från användaren om att ämnet används under strängt kontrollerade förhållanden enligt beskrivningen i artikel 18.4 i Reach. I sådant fall är både registranten och användarna ansvariga för sina egna uppgifter om de strängt kontrollerade förhållandena.
När och hur de olika bestämmelserna för registrering av intermediärer enligt Reach kan användas beskrivs i Vägledning om intermediärer: http://echa.europa.eu/guidance-documents/guidance-on-reach.

Mer information finns på https://echa.europa.eu/documents/10162/13655/pg16_intermediate_registration_sv.pdf
 

How can a registration dossier be corrected in case a mistake was made in the preparation of the dossier?
After you have submitted your registration dossier to ECHA you may realise that you made a mistake during its preparation. This might be the case, for example, if you accidentally introduced faulty information in the dossier (e.g. incorrect information in one of the study summaries) and noticed this only after you submitted the dossier to ECHA. In this case you should without undue delay submit the amended dossier as a spontaneous dossier update via REACH-IT, indicating in the dossier header the reason(s) why you are spontaneously updating it as well as the references of the previous valid submission (i.e. the "last submission number"). Such an update would not be subject to a fee, unless the mistake is related to a chargeable element such as an increase in tonnage band, or confidentiality claims for information listed in Article 119(2).
 
Some mistakes may prevent a successful submission of the dossier to ECHA. These are failures in the business rules or the completeness check. If your submission fails either of these checks, you will be alerted to the failure in the form of a task in REACH-IT, which prompts you to amend the dossier. For more information on these topics, please refer to the following Q&A entries:
 
What should I do if there is no SIEF Formation Facilitator (SFF) in my pre-SIEF?

The SFF role was created to initiate and conduct discussions after pre-registration, and to facilitate the exchange of information and data required to form the SIEF. However, the SFF role is not formally recognised under REACH and potential registrants have no legal obligation to use an SFF to form a SIEF. If no pre-SIEF member has taken the initiative to take on the role of SFF or the SFF is inactive, you should contact the other pre-SIEF members to know more about the status of your SIEF.

The pre-SIEF is the first step for recognising potential registrants of the same substance and help you to start discussions on substance identity and substance sameness. SIEFs are expected to start communicating and organising themselves outside the REACH-IT environment. ECHA recommends that potential registrants contact their relevant trade associations to receive further advice on how to evolve from pre-SIEFs to SIEFs.

Do chromic acids and their oligomers, generated in water from chromium trioxide, require their own registration under REACH?

When brought in contact with water, chromium trioxide (EC number 215-607-8) forms two acids and several oligomers: Chromic acid (EC number 231-801-5), Dichromic acid (EC number 236-881-5), Oligomers of chromic acid and dichromic acid.

These chemical species are identified as substances of very high concern (SVHC) and included in the Candidate List1 as two separate entries.

Chromic acids and their oligomers generated in water from chromium trioxide are commonly referred to as an aqueous solution of chromium trioxide. With regard to the obligation to register, it may be justifiable in some specific situations described in the table below, to consider for practical reasons chromic acids and their oligomers as an aqueous solution of chromium trioxide. Hence, in these specific cases, chromic acids and their oligomers present in an aqueous solution of chromium trioxide can be covered by a registration dossier for chromium trioxide.

Important note: The presented approach is strictly limited to chromium trioxide and chromic acids and their oligomers generated from chromium trioxide in water. It derives from very specific aspects of the Chromium VI aqueous chemistry; the system in aqueous solution is a complex equilibrium between multiple chemical species which depends on several physico-chemical parameters and the different chemical species cannot be isolated from the aqueous solution. The approach can thus not be applied by analogy to any other substance.

Manufacturers and importers of chromium trioxide and chromic acids and their oligomers have to consider the following situations:

 

Actor / Scenario Legal requirement Explanation
Manufacturer or importer of chromium trioxide who generates chromic acids and their oligomers in water One registration according to Article 10 for chromium trioxide

The generation of chromic acids and their oligomers by adding chromium trioxide to water and their further use have to be included in the registration dossier and have to be considered for the chemical safety assessment (CSA) and the chemical safety report (CSR).

In case a downstream user (DU) generates chromic acids and their oligomers from chromium trioxide, this use has to be communicated up the supply chain and has to be included in the registration dossier.

Importer of both chromium trioxide and chromic acids and their oligomers generated in water from chromium trioxide

One registration according to Article 10 for chromium trioxide The registrant has to register chromium trioxide and chromic acids and their oligomers in one dossier for chromium trioxide. It has to become clear from the registration dossier that chromic acids and their oligomers are also imported. Therefore, at least two compositions have to be provided in section 1.2 of the IUCLID dossier. The first composition refers to chromium trioxide; the second composition refers to the composition of chromic acids and their oligomers. A remark has to be entered to clarify the approach.  The tonnage to be reported is the aggregated tonnage of both chromium trioxide and chromic acids and their oligomers. The tonnage has to be reported on the basis of equivalent chromium trioxide tonnage. 
Importer of chromic acids and their oligomers generated in water from chromium trioxide Registration according to Article 10
either for chromic acids and their oligomers generated from chromium trioxide
or for chromium trioxide

In case the importer decides to register chromic acids and their oligomers in a dossier for chromium trioxide, it has to become clear from the registration dossier that what is actual imported are chromic acids and their oligomers.

Therefore at least two compositions have to be provided in section 1.2 of the IUCLID dossier. The first composition refers to the generic substance "chromium trioxide"; its purity and composition should be indicated as 100 %. The second composition shall refer to the actual composition of chromic acids and their oligomers which are imported. A remark has to be entered to clarify the approach.  
Manufacturer or importer of chromic acids and their oligomers generated by alternative methods other than from adding chromium trioxide to water
or
Importer who is unaware of the manufacturing methods of the chromic acids and their oligomers
Registration according to Article 10 for chromic acids and their oligomers The approaches described above cannot be applied as the starting material for manufacturing chromic acids and their oligomers is not chromium trioxide or is not known. 

 

Please, also see Q&A=805 (Can an application for authorisation for chromium trioxide cover the use of the chromic acids and their oligomers generated from adding chromium trioxide to water?)

How do I register if I am located outside the EEA?
What are some examples of manufacturing?

Under REACH, manufacturing means producing or extracting substances in their natural state. It is a case-by-case decision to establish the extent to which the different steps in producing the substance are covered by the definition ‘manufacturing'.

Example
A company that purchases registered substances from within the EU and then formulates these into mixtures (e.g. paints) would be regarded as a downstream user under REACH.

In layman's terms, this company might be considered to be a manufacturer of paints. However, within the context of REACH, the company would not be a manufacturer of a substance and so would have no registration obligations for these substances. For further information see the Guidance on registration (http://echa.europa.eu/documents/10162/13632/registration_en.pdf). Examples on manufacturing on intermediates available in the Guidance on intermediates and Practical Guide 16.

Hur avgör jag vem som ansvarar för importen?

Du ansvarar för registreringen om du är den juridiska enhet som är etablerad i EU och ansvarar för importen.

Ansvaret för importen beror på många faktorer, bland annat:

  • Vem är det som beställer?
  • Vem betalar?
  • Vem ansvarar för tullformaliteterna?
    Men det är inte säkert att enbart detta är avgörande.

Exempel
En försäljningsagentur som är etablerad i EU och som agerar som mellanhand, dvs. som förmedlar en beställning från en köpare till en leverantör utanför EU (och får betalt för denna tjänst), men som inte tar något som helst ansvar för varorna eller betalningen av varorna och som inte äger dem i något skede. I detta fall betraktas försäljningsagenturen inte som importör enligt Reach. Försäljningsagenturen ansvarar inte för den fysiska införseln av varorna.

I flera fall är försäljningsagenturen den sista varumottagaren som är den juridiska enhet som ansvarar för importen av varorna.

Mer information och ytterligare exempel finns i kapitel 2.1.2.4 ”Vem ansvarar för registreringen vid import?” i Vägledning om registrering:

Hur dokumenterar jag att mina leverantörer har utsett en enda representant?

Om dina leverantörer är etablerade utanför EU och bestämmer sig för att utse en enda representant kommer de att skicka en bekräftelse om detta till alla importörer. Du bör företrädesvis även få en skriftlig bekräftelse från den enda representanten på att den importerade mängden och användningen verkligen omfattas av registreringsunderlaget.

Detta ger dig inte bara en kontaktperson som du kan lämna information till om din användning, utan utgör även en tydlig dokumentation om att din import verkligen omfattas av den enda representantens registrering.

Du måste dokumentera exakt vilka mängder av det importerade ämnet som omfattas av registreringen av den enda representanten och vilka mängder som inte gör det. Mer information finns i kapitel 2.1.2.5 ”Enda representant för en 'tillverkare utanför EU'” i Vägledning om registrering:

Hur dokumenterar jag återimport av registrerade ämnen?

Ämnen som har registrerats och som exporteras och därefter återimporteras är undantagna från registreringsplikten under vissa omständigheter.

För att kunna utnyttja detta undantag måste du dokumentera att följande villkor är uppfyllda:

  1. Ämnet måste ha registrerats innan det exporterades från EU.
  2. Det ämne som redan har registrerats och exporterats måste vara detsamma som det ämne som återimporteras.
  3. Ämnet måste inte bara vara detsamma utan måste även komma från den distributionskedja där ämnet registrerades.
  4. Återimportören måste ha försetts med information om det exporterade ämnet enligt kraven i Reach (t.ex. säkerhetsdatablad).

Mer information finns kapitel 2.2.3.6 ”Återimporterade ämnen” i Vägledning om registrering:

Hur dokumenterar jag ämnen som är föremål för tullövervakning?

Om ämnen befinner sig i tillfällig förvaring för att återexporteras och förblir föremål för tullövervakning omfattas de inte av Reach.

För att kunna åberopa detta undantag måste du dokumentera att följande villkor är uppfyllda:

  1. Ämnena placeras i en frizon eller i ett frilager enligt tullagstiftningens definition eller blir föremål för annat relevant tullförfarande (transitering eller tillfällig lagring).
  2. Ämnena är föremål för tullmyndighetens övervakning.
  3. Ämnena genomgår inte någon behandling eller bearbetning medan de befinner sig i EU. En frizon eller ett frilager inom EU:s territorium ingår i EU.

Mer information finns i kapitel 2.2.2.2 ”Ämnen som är föremål för tullövervakning” i Vägledning om registrering:

Vad finns det för exempel på varor med avsiktlig avgivning av ämnen?

Ett ämne kan vara avsett att avges från en vara för att ge den ett mervärde. Parfymerade barnleksaker är exempel på sådana varor med avsiktlig avgivning av ämnen, eftersom de doftämnen som ingår i leksaken är avsedda att avges för att ge varan ett mervärde, i det här fallet en behaglig doft.

Ett exempel på motsatsen är bläckpatroner eller våtservetter. I dessa fall är det möjligt att fysiskt separera ämnena från varan. De är därför inte att betrakta som ämnen i en vara, utan snarare som ämnen i en behållare.

Detta innebär att leverantören av bläckpatronerna betraktas som leverantör av ett ämne och den allmänna registreringsskyldigheten gäller.

Mer information finns i Vägledning om krav för ämnen i varor:

Hur fastställer jag om ämnet i min vara redan har registrerats för en viss användning?

Om man vill ta reda på vilka användningar ett ämne har registrerats för måste man i de flesta fall vända sig till andra aktörer högre upp i distributionskedjan.

För att göra detta måste du beskriva ämnets funktion i varan, processen genom vilken ämnet införlivas i varan och i vilken typ av vara det rör sig om. Beskrivningen bör följa systemet med användningsdeskriptorer.

Säkerhetsdatablad (SDS) kan vara till hjälp eftersom de innehåller information om användningar av ämnet eller blandningen i den utsträckning leverantören känner till dem. Om ett säkerhetsdatablad dessutom inbegriper ett registreringsnummer kan det, beroende på hur utförliga användningsbeskrivningarna i säkerhetsdatabladet är, vara möjligt att dra slutsatsen att en särskild användning av detta ämne redan har registrerats. Vid osäkerhet bör du dock vända dig till den faktiska registranten högre upp i distributionskedjan för bekräftelse.

Man kan också kontakta tillverkare eller importörer i en annan distributionskedja för att fråga vilka användningar de har registrerat ämnet för eller om de har registrerat ämnet för en särskild användning.

En bra metod för att leta upp tillverkare och importörer av ett ämne är att sända in en förfrågan inom forumet för informationsutbyte om ämnen (SIEF). Den som sänder in en förfrågan måste först ha förhandsregistrerat ämnet eller anslutit sig till forumet som datainnehavare.

Mer information finns i Vägledning om krav för ämnen i varor:

Vad har jag för skyldigheter som enda representant?

Som enda representant är du fullt ut ansvarig för att alla skyldigheter som gäller importörer fullgörs för de ämnen som du ansvarar för. Detta gäller inte enbart registreringen utan även alla andra skyldigheter som importörer har enligt Reach. Som enda representant ska du registrera de importerade mängderna, beroende på avtalen med ”tillverkaren utanför EU”.

Du kan representera en eller flera ”tillverkare utanför EU”. Om du representerar flera ”tillverkare utanför EU” måste du lägga fram en separat registrering för var och en av tillverkarna.

Registreringsunderlaget ska innehålla alla importörens användningar som omfattas av registreringen. Du ska spara en aktuell förteckning över de importörer som ”tillverkaren utanför EU” har inom samma distributionskedja och den mängd som omfattas för var och en av dessa, liksom information om den senaste uppdateringen av säkerhetsdatablad som har skickats ut.

Mer information finns i kapitel 2.1.2.5 ”Enda representant för en ’tillverkare utanför EU’” i Vägledning om registrering:

Vad ska jag göra om jag överskrider volymgränsen på 100 ton per år?

Varje år måste du beräkna den årliga volymen genom att ta fram ett genomsnitt för de tre föregående åren.

Exempel

Ditt företags volymer är 60 ton 2013, 90 ton 2014, 140 ton 2015 och 200 ton 2016. Den genomsnittliga volymen för tre år i följd blir 97 ton/år för 2016 men 143 ton/år för 2017.

I detta fall måste du registrera ämnet så fort som möjligt eftersom tidsfristen för registrering av ämnen som uppgår till över 100 ton per år gick ut den 31 maj 2013. Registreringsskyldigheten baseras på volymen för 2017 som är ett genomsnitt för åren 2014–2016, dvs. 143 ton.

Eftersom årsvolymen bygger på ett genomsnitt för tre år borde det bli enklare för företagen att förutse en eventuell ökning av årsvolymen.

Mer information finns i vägledningen om registrering:

Hur definieras en polymer enligt Reach?

En polymer är ett ämne som består av molekyler som är uppbyggda av en sekvens av en eller flera typer av monomerenheter. Molekylerna ska vara fördelade över en rad molekylvikter. Skillnaden i molekylvikt kan främst hänföras till skillnader i antalet monomerenheter.

Enligt Reach definieras en polymer som ett ämne som uppfyller följande kriterier:

  1. Över 50 procent av vikten utgörs av molekyler som innehåller åtminstone tre monomerenheter kovalent bundna till åtminstone en annan monomerenhet eller en annan reaktant, samt
  2. mängden polymermolekyler som har samma molekylvikt måste utgöra mindre än 50 procent av vikten.

För mer information, se kapitel 2.2.3.7 ”Polymerer” i Vägledning om registrering:

Mer ingående information om polymerer finns i Vägledning beträffande monomerer och polymerer:

Vilka ämnen omfattas av bilaga V?
I bilaga V ingår tretton breda ämneskategorier för vilka registrering anses olämplig eller onödig. Registreringsundantaget gäller ämnen som sådana, förutsatt att de uppfyller kriterierna för undantaget som ges i den särskilda kategorin i bilaga V.
 
Mer information om varje ämneskategori finns i Vägledning för bilaga V. Där hittar du förklaringar och bakgrundsinformation om hur olika undantag tillämpas och förtydliganden av när ett undantag kan tillämpas och inte.
 
Vilka ämnen är undantagna från registreringsplikten därför att de används för försvarsändamål?

Reach-förordningen tillåter i vissa fall att enskilda medlemsstater av försvarsintresse undantar vissa ämnen från tillämpningen av Reach.

Mer information om nationella undantag av försvarsintresse i enskilda medlemsstater finns på Europeiska försvarsbyråns webbplats (http://www.eda.europa.eu/reach).

Hur definieras en icke-isolerad intermediär enligt Reach?

En icke-isolerad intermediär definieras som en intermediär som under syntesen inte avsiktligt avlägsnas från den utrustning i vilken syntesen sker (utom vid provtagning).

Mer information finns i Vägledning om registrering:

Vilka ämnen som används i livsmedel eller djurfoder är undantagna från registreringsplikten?

Då ett ämne används i livsmedel för människor eller i djurfoder i enlighet med livsmedelssäkerhetsförordningen (EG) nr 178/2002, behöver ämnet inte registreras.

Detta innefattar användningen av ämnet

  • som livsmedelstillsats (rådets direktiv 89/107/EEG),
  • som aromämne i livsmedel (rådets direktiv 88/388/EEG och kommissionens beslut 1999/217/EG),
  • som djurfodertillsats (förordning (EG) nr 1831/2003),
  • i djurfoder (rådets direktiv 82/471/EEG).

Mängder av samma ämne som används för andra användningar än livsmedel och djurfoder undantas inte från registreringsplikten. Endast de mängder av ämnet som används i livsmedel och djurfoder är undantagna från registrering enligt Reach.

För mer information, se kapitel 2.2.3.1 ”Livsmedel eller djurfoder” i Vägledning om registrering:

Vilka ämnen som används i läkemedel är undantagna från registreringsplikten?

Ett ämne behöver inte vara registrerat enligt Reach för användningen i fråga om ämnet används i läkemedel som omfattas av följande förordning eller direktiv:

  • Förordningen om inrättande av gemenskapsförfaranden för godkännande av och tillsyn över humanläkemedel och veterinärmedicinska läkemedel samt om inrättande av en europeisk läkemedelsmyndighet ((EG) nr 726/2004).
  • Direktivet om upprättande av gemenskapsregler för veterinärmedicinska läkemedel (2001/82/EG).
  • Direktivet om upprättande av gemenskapsregler för humanläkemedel (2001/83/EG).

Undantaget skiljer inte mellan aktiva och icke aktiva innehållsämnen, eftersom det gäller alla ämnen ”som används i läkemedel”. Därför är även hjälpämnen som används i läkemedel undantagna från registreringsplikten.

Mängder av samma ämnen som används för andra användningar än läkemedel är inte undantagna. Endast de mängder av ämnet som används i läkemedel är undantagna från registreringsplikten.

För mer information, se kapitel 2.2.3.2 i Vägledning om registrering:

Vilka ämnen som används i biocidprodukter betraktas som registrerade?

Verksamma ämnen som tillverkas eller importeras för användning i biocidprodukter betraktas som registrerade för användningen i den biocidprodukten i följande situationer:

  • Det verksamma ämnet har godkänts i enlighet med förordning (EU) nr 528/2012 (biocidförordningen, BPR), eller
  • en granskning av det verksamma ämnet pågår inom ramen för granskningsprogrammet för befintliga verksamma ämnen som inrättades enligt artikel 16.2 i direktiv 98/8/EG och har fortsatt i enlighet med artikel 89 i BPR.

Förteckningen över godkända verksamma ämnen finns på Echas webbplats:

Om du vill kontrollera vilka verksamma ämnen som behandlas inom granskningsprogrammet, se bilaga II, del I till kommissionens delegerade förordning (EU) nr 1062/2014, som även finns på Echas webbplats:

http://echa.europa.eu/regulations/biocidal-products-regulation/approval-of-active-substances/existing-active-substance

Undantag från registreringsplikten enligt Reach gäller även i följande fall:

  • Det verksamma ämnet tillverkas/importeras för användning i en biocidprodukt som godkänts i enlighet med det förenklade produktgodkännandeförfarandet (artikel 27 i BPR).
  • Det verksamma ämnet tillverkas/importeras för användning i en biocidprodukt som har ett tillfälligt produktgodkännande (artikel 55 i BPR).
  • Det verksamma ämnet tillverkas/importeras uteslutande för att användas i en biocidprodukt som används för experiment eller försök i forskningssyfte eller för produkt- och processinriktad forskning och utveckling (artikel 56 i BPR).

Om du tillverkar eller importerar ett ämne för användning i biocidprodukter och för annan användning måste du registrera ämnet för den mängd av ämnet som används i produkter som inte är biocidprodukter.

Vilka ämnen som används i växtskyddsmedel betraktas som registrerade?

Verksamma ämnen som tillverkas eller importeras för användning i växtskyddsmedel i enlighet med förordning (EG) nr 1107/2009 om utsläppande av växtskyddsmedel på marknaden betraktas som registrerade enligt Reach (för den användningen) om det verksamma ämnet är godkänt och finns upptaget i kommissionens tillämpningsförordning (EG) nr 540/2009 (förteckning över godkända verksamma ämnen) eller om ansökan om godkännande av det verksamma ämnet har godtagits enligt 9 i förordning (EG) nr 1107/2009.

Mängder av samma verksamma ämne som används för andra ändamål än växtskyddsmedel betraktas inte som registrerade även om de är godkända. Dessutom betraktas andra ämnen, såsom formuleringsämnen, synergister, skyddsämnen och hjälpämnen, inte som registrerade.

Kommissionen upprätthåller en elektronisk förteckning över godkända (och icke-godkända) verksamma ämnen. Den finns tillgänglig via följande länk:

http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.selection&language=EN

När ska ett återvunnet ämne registreras?

Ett återvunnet ämne ska registreras så snart det inte längre betraktas som avfall (när det uppfyller kriterierna för att upphöra vara avfall).

Mer information om kriterierna för när avfall upphör att vara avfall:

Hur dokumenterar jag att ett återvunnet ämne redan är registrerat?

För att undantaget ska kunna utnyttjas måste du dokumentera att följande villkor är uppfyllda:

  1. Samma ämne måste ha varit registrerat.
  2. Ämnet måste vara detsamma.
  3. Företaget som genomförde återvinningen måste ha den information som krävs enligt Reach tillgänglig (t.ex. säkerhetsdatablad).

För mer information, se kapitel 2.2.3.5 ”Återvunnet ämne som redan registrerats” i Vägledning om registrering:

Vilka ämnen omfattas av bilaga IV?
I bilaga IV ingår ett antal ämnen för vilka man anser att det finns tillräcklig information tillgänglig för att betrakta dem som ämnen som ger upphov till minimal risk för människors hälsa och miljön.
 
Dessa ämnen är vanligen av naturligt ursprung och förteckningen över undantagna ämnen omfattar exempelvis vatten och kväve. Ämnen som ingår i bilaga IV är undantagna från registreringsbestämmelserna.
 
Undantagen från registrering gäller ämnet som sådant, inte någon viss användning.
 
För mer information, se bilaga IV till Reach-förordningen:
 
I pre-registered a substance which was not listed in the EINECS. In the list of pre-registered substances published by ECHA, a "list number" has been assigned to my substance. Should I report this list number in my registration dossier?

The list numbers published by ECHA are not official EC entries. However, we recommend you to assign such an entry to the phase-in substance you intend to register provided this list number is linked to a CAS number (list numbers starting with 6 or 8) or a chemical name (list numbers starting with 9) corresponding to a correct and specific identifier for your substance. If this entry is too generic for your substance and there is no appropriate EC entry available, you should not assign any list/EC number to your substance.

How do I proceed if I have concerns about confidential business information (CBI) when discussing substance sameness?

Consider taking specific measures in the SIEF to protect information that you consider CBI, but you nevertheless need to share with the SIEF to conclude on the substance sameness. You can, for example:

  1. Have confidentiality agreements that limit access to documents or other information to specific named persons, or departments; and
  2. Allow access to certain documents in a ‘reading room’ only (where copying is not allowed); and
  3. Agree to have certain documents reviewed and/or assessed only by a third party expert (independent consultant) or a trustee.

You can strengthen this by having additional personal confidentiality agreements for those who get access to the CBI documents. 

As a minimum, you should specify to the other SIEF members that the information is indeed CBI and, therefore, you communicate it and it can be used only for purposes of the verification of substance identity under REACH.

For more information on CBI, see section 9 of the Guidance on Data-sharing (https://echa.europa.eu/guidance-documents/guidance-on-reach).

I now have my registration number. What happens next?

Your registration dossier remains your responsibility. You need to keep it up to date.

If you need to give your customers safety data sheets, you will need to include your registration number in the safety data sheets the next time you update them. In addition, if you have conducted a chemical safety assessment and needed to develop exposure scenarios, you have to attach them to the safety data sheet, outlining the use-specific conditions of safe use of the substance. This needs to be done as soon as possible.

If you have claimed you are an SME and have benefited from the reduced registration fees, ECHA may verify the size of your company. Make sure that your REACH-IT account includes all the necessary documentation to justify the size of your company.

We strongly recommended that you discuss within your joint submission and your company to put a mechanism in place to update the registration dossier, if necessary. For example, you must also share data and give access to the joint submission to newcomers. You can charge for access to the data by sharing the costs in a fair, transparent and non-discriminatory way.

ECHA will check the compliance of at least 5 % of the received registration dossiers to verify that the information submitted is compliant with the legal requirements. The outcome of this dossier evaluation may be a request for additional information. Additionally, by 1 June 2022, ECHA will examine the testing proposals included in the dossiers.

Remember to keep a close eye on your REACH-IT account – we will communicate with you only through it.

Why have I not received a registration number even though I submitted my registration dossier on time?

There can be a number of reasons for this. Have a look at the scenarios below.

If you submitted your registration on time, you can continue to manufacture or import your substance even if you have not yet received your registration number. You would need to cease manufacture or import only if ECHA rejects your registration.

Your dossier is considered as ‘submitted’ when it passes the business rules step. You are informed about it through your REACH-IT account and ECHA then assigns a submission number and a submission date to your dossier. The proof that you have submitted a registration dossier is this submission number and submission date that you have received in your submission report in REACH-IT. If you are a lead registrant, it is only after your lead registrant dossier has passed the business rules check that the member registrants can submit their own dossiers.

If your dossier has failed the business rules check, you have also been informed about it through your REACH-IT account. In this case, you have missed the legal deadline and are not entitled to manufacture, import or market the substance in the EU/EEA. You can only start manufacturing or importing again once you have submitted a complete registration dossier and received a registration number from ECHA. In the meantime, you may place on the market any stocks you might have (Reference: Q&A 40). Submit a registration dossier as a matter of urgency! Document your submission attempts so that you can demonstrate that you took corrective action as soon as you could.

Scenario 1: ECHA is still processing your dossier

ECHA has until the end of August 2018 to verify the completeness of the dossiers that were submitted in April and May 2018. Keep track of the progress through your REACH-IT account. In the meantime, you can continue manufacturing or importing your substance.

Scenario 2: You have not paid the registration fee

Your registration will only be complete once ECHA has confirmed that your registration includes all the required information and you have paid the fee indicated in the invoice you have received through your REACH-IT account.

If you do not pay by the initial payment deadline indicated in the invoice, you will automatically be granted an extension. However, if you do not pay by this extended deadline, ECHA will reject your registration. You will have to cease manufacturing or importing activities, as you can only legally manufacture, import or market your substance once you have successfully registered it. In the meantime, you may place on the market any stocks you might have (Reference: Q&A 40).

Scenario 3: Your dossier has failed the first technical completeness check

In this scenario, we will tell you what needs to be done and what the deadline is for submitting the missing information. You will have at least four months for this, so invest time in fixing the errors reported before resubmitting the full information as an update. You only have this one last chance to update your dossier so that it passes the technical completeness check. Make sure that you follow the instructions carefully and provide all the information requested, and only resubmit when you are sure you have addressed all failures.

Use the Validation assistant tool in IUCLID to avoid the risk of failing again – you will not get a third chance. If you still have questions, contact ECHA to make sure you understand what you need to do to complete your dossier.

Scenario 4:  Your dossier has been rejected as it has failed the technical completeness check a second time

You will have to start the registration process all over again and resubmit your dossier as an initial submission. Any fee that you paid in connection with your failed first registration will not be refunded.

You will have to stop manufacturing or importing activities, as you can only legally manufacture, import or market your substance if you have successfully registered it. In the meantime, you may place on the market any stocks you might have (Reference: Q&A 40).

What should I do if I did not submit my registration dossier by 31 May 2018 deadline?

31 May 2018 was the last chance to submit a registration for existing (phase-in) substances manufactured or imported in amounts of more than one tonne per year. If the registration obligation applied to you, but you did not submit your dossier by then, as of 1 June you can no longer manufacture or import your substance legally in the EU/EEA. You may, however, continue placing on the market any stock that was manufactured/imported before the deadline.

If you missed the deadline, you should make yourself compliant without delay:

  • If you have pre-registered or inquired about your phase-in substance, you can register it directly (until further notice, you can still use the pre-registration number).
  • If you have not pre-registered or inquired about your phase-in substance, you need to submit an inquiry before registering it.

If you submit your dossier after 31 May, you will need to wait until you receive your registration number before resuming or starting manufacture or import of your substance.

 

What is the status of pre-registrations?

In principle, pre-registration numbers do not carry any meaning anymore. Substances manufactured or imported in quantities of more than one tonne per year in the EU/EEA must be registered unless they are exempt from the obligations under the REACH Regulation.

How do I know whether or not a substance has been registered?

Have a look at the lead registrant list, which is frequently updated. It shows the substances for which the registration process has been started and those to which a registration number has already been assigned. You can also check the list of registered substances on ECHA’s website. However, do note that not all registration dossiers have yet been published, as some are still being processed by ECHA.

You can see the names of registrants by viewing the information on ECHA’s website. The company names appear at the bottom of the ‘General Information’ section. However, in some cases, this may not include your specific supplier, such as when:

  • your supplier is not the one manufacturing or importing the substance; or
  • the registrant has successfully claimed the name as confidential or is an importer covered by a representative of the non-EU exporter.

The most reliable information should come from your supplier. Again, the longer the supply chain, the longer it will take for this confirmation to arrive to you.

My use is not covered by my supplier’s registration. What should I do?

You have several options, ranging from asking your supplier to include your use in their registration to preparing your own chemical safety report or adapting/stopping the use of the substance:

  1. Ask your supplier to include your use or conditions of use in their chemical safety report and to provide you with an exposure scenario for it. You need to make sufficient information available to your supplier to enable them to make such an assessment. Your sector organisation may have developed a convenient means of supplying this information specifically to your sector.
  2. Implement the conditions of use described in the exposure scenario you have received. This option may require changes to your processes or products.
  3. Eliminate the substance or activity or substitute it with a safer alternative.
  4. Find another supplier who can provide the substance with a safety data sheet and an exposure scenario covering your use.
  5. Carry out your own chemical safety assessment and prepare your own downstream user chemical safety report (DU CSR) for your uses and conditions of use, unless exemptions apply – see our practical guide How to prepare a downstream user chemical safety report for details. You will have to notify ECHA about this.

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