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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.

Who is the registrant in case of toll manufacturing of substances?

A toll manufacturer is normally understood to be a company that manufactures a substance (on its own, in a mixture or in an article) in its own technical facilities following the instructions of a third party in exchange for an economic compensation. The substance is generally put on the market by the third party. This construction is, for example, used for an intermediate step in the production process for which sophisticated equipment is needed (distillation, centrifugation etc.). According to the REACH Regulation, manufacturers of substances are required to register the substances they manufacture above one tonne per year. From this point of view the toll manufacturer is a manufacturer and has to register the substance.

This scenario is further discussed in the factsheet ‘Toll manufacturer under the REACH Regulation' available under the following link:
http://echa.europa.eu/documents/10162/13634/factsheet_toll_manufacturer_en.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 intermediates?

It depends under which type of intermediate as described under Article 3(15) of the REACH Regulation your intermediate falls, whether you have registration obligations or not.

  • Non-isolated intermediates:

For the use of a substance as a non-isolated intermediate, there are no obligations under the REACH Regulation.

  • On-site isolated intermediates:

A manufacturer of on-site isolated intermediates in quantities of 1 tonne or more per year needs to register their substances (if they are not otherwise exempted from registration (see FAQ ID=30). However registrants of on-site isolated intermediates can provide reduced registration information according to Article 17(2) of the REACH Regulation if they confirm that the substance is manufactured and used under strictly controlled conditions as described under Article 17(3) of REACH.

  • Transported isolated intermediates:

A manufacturer or importer of transported isolated intermediates in quantities of 1 tonne or more per year needs to register his substances if they are not otherwise exempted from registration. However, a registrant of transported isolated intermediates can provide reduced registration information according to Article 18(2) of the REACH Regulation if he confirms that he is manufacturing and/or using the substance under strictly controlled conditions and if he confirms or states that he has received confirmation from the user that the substance is used under strictly controlled conditions as described under Article 18(4) of REACH. In this case, both the registrant and the users are each liable for their own statement regarding the strictly controlled conditions.
When and how the specific provisions for the registration of intermediates under REACH can be used are described in the Guidance for intermediates: http://echa.europa.eu/guidance-documents/guidance-on-reach.

More information can be found at: http://echa.europa.eu/documents/10162/13655/pg16_intermediate_registration_en.pdf
 

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.
What falls under the definition of PPORD (Product and Process Oriented Research and Development)?
According to Article 3 (22) of the REACH Regulation PPORD is defined as "any scientific development related to product development or the further development of a substance, on its own, in preparations or in articles in the course of which pilot plant or production trials are used to develop the production process and/or to test the fields of application of the substance".Any scientific development of a substance consisting of, for example, campaign(s) for the scaling-up, improvement of a production process in a pilot plant or in the full-scale production, or the investigation of the fields of applications for that substance, falls under the definition of PPORD irrespective of the tonnage involved.
In order to promote innovation, Article 9 of the REACH Regulation specifies that substances manufactured or imported on their own or in mixtures, as well as substances incorporated in articles or imported in articles for the purpose of PPORD can be exempted from the duty to register for a period of 5 years. To be exempted a company needs to submit a PPORD notification to the ECHA. Upon request, ECHA may further extend this exemption for up to another 5 years, or 10 years for the development of medicinal products (for human or veterinary use) as well as for substances that are not placed on the market. Further information is provided by the specific Guidance on Scientific Research and Development (SR&D) and Product and Process Oriented Research and Development (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?

The answer to this question depends on your role at the time when the registration obligation applies.

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

  • manufactured or imported pre-registered substances before the registration deadline; and
  • ceased such activities and simply acted as a supplier after that.

If you have not ceased your activities before the relevant registration deadline, you must submit a registration dossier for all quantities of the substance manufactured or imported before and after the respective registration deadline.

In any case, any actor down the supply chain who is not subject to the registration obligation may continue to use and/or supply quantities of the substance that you have supplied to them before the registration deadline.

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?
Various aspects need to be taken into account when considering the registration deadlines. These include tonnage, dangerous properties, and whether it is a phase in or a non-phase in substance. Information on these aspects is provided in Chapter 2.3- 'When to register?' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.
 
The REACH Regulation creates a special transition regime for phase-in substances (Section 2.3.1.1- 'Phase-in substances' of the Guidance on registration). In order to benefit from the extended registration deadlines for phase-in substances (Section 2.3.2- 'Deadlines for Registration' of the Guidance on registration, these substances must be pre-registered (see also FAQ ID=23). Depending on its intrinsic properties and its tonnage, a pre-registered substance needs to be registered before 1 December 2010, 1 June 2013 or 1 June 2018.
 
Non-phase-in substances and phase-in substances which have not been pre-registered must be registered before manufacture or import can continue. In this case the registrant may have to wait for 3 weeks before continuing manufacture or import (Article 21 of the REACH Regulation). Prior to registration of such substances, the manufacturer or importer has a duty to make an inquiry to ECHA regarding any previous registration for that substance.
How do I calculate the tonnage?

Each registrant has to calculate the yearly tonnage for the registration dossier. The yearly tonnage is calculated as the volume per manufacturer/importer per calendar year, unless stated otherwise. For phase-in substances that have been imported or manufactured for at the least three consecutive years, quantities are calculated on the basis of the average production or import volumes for the three preceding calendar years (Article 3 (30) of the REACH Regulation). Detailed guidance and practical examples are provided in Section 2.2.6 'Calculation of the volume to be registered' of the Guidance on registration: 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.

How much is the registration fee?

The registration fee for a substance depends on the tonnage of registration, size of the company and the type of submission. Additionally:

  •  Lower fees and charges apply to joint submissions as compared to separate submissions. This does not  apply in case you opt out of the joint submission;
  •  SMEs benefit from a reduced fee in all categories;
  •  An additional fee is levied for confidentiality.

No fee is required for the registration of substances in a quantity between 1 and 10 tonnes per year when a registration containing all the information in Annex VII, which is the basic set of information requirements for substances manufactured or imported at or above 1 tonne.
All these provisions are specified in Article 74 of REACH. The fees are developed in the Commission Fee Regulation (No. 340/2008). Further information can be found in the REACH-IT FAQs on "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.
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 you may realise that your registration dossier has to be corrected or modified for reasons other than those triggering the need for an update of the registration according to Article 22 of the REACH Regulation. 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, which however does not affect the assessment of the substance made) and noticed this only after you submitted the dossier to ECHA. In this case you should make 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.
 
If the mistake leads to a failure in the business rule verification, then instead of a spontaneous update submission an initial submission has to be made, as if it was the first dossier submission. Part 4 of the REACH-IT Data Submission Manual describes how to pass the business rule verification.
Is there any obligation according to Article 21 of REACH to interrupt the manufacture or import of the substance during the technical completeness check (TCC)?
In case the manufacture or import is only to be started, e.g. in case of a non phase-in substance, the waiting period must be respected.
 
On the other hand, there is no requirement to interrupt manufacture or import of phase-in substances during the TCC. However, when the initial submission of a phase-in substance was incomplete, ECHA will give the registrant a deadline to complete the dossier. Until the end of this deadline, the registrant is allowed to continue his activities. If he does not update the dossier, the registrant must cease manufacture or import by this deadline at the latest. If he updates his dossier, the registrant can continue the manufacture or import of the substance until he receives the decision by ECHA on the outcome of the completeness check. If he receives a decision rejecting his registration, he must cease manufacture or import of the substance.
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.
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.

How do I determine who is responsible for importing ?

You should register if you are the legal entity established in the EU who is responsible for importing.

The responsibility for importing depends on many factors such as:

  • Who orders?
  • Who pays?
  • Who is dealing with the customs formalities?
    However, this might not be conclusive on its own.

Example
A sales agency established in the EU that acts as an intermediary, i.e. they transmit orders from buyers to non-EU suppliers (and are paid for this service). However, they take no responsibility for the goods or the payment of the goods and do not own the goods at any stage. In this case, the sales agency is not considered to be an importer for the purposes of REACH. The sales agency is not responsible for the physical introduction of the goods.

In many instances, this will be the ultimate receiver of the goods (the consignee) who is the legal entity responsible for importing the goods.

For further information and examples see chapter 2.1.2.4 "Who is responsible for registration in case of import?" in the Guidance on registration:

How do I document that my suppliers have appointed an only representative?

If your suppliers are located outside the EU and decide to appoint an only representative, they will confirm this to all the importers. You should preferably also obtain confirmation in writing from the only representative that your imported tonnage and use is indeed covered by the registration dossier.

This would not only provide you with a contact point with whom you can make your use known, but would also clearly document that your imports are indeed covered by the registration of the only representative.

You need to keep exact documents on which imported quantities of the substance are covered by the only representative registration and which imported quantities are not. For further information see chapter 2.1.2.5 "Only representative of a non-EU manufacturer" in the Guidance on registration:

How do I document the re-import of a registered substance?

Substances which have been registered, exported and then re-imported are exempted from registration under certain conditions.

To benefit from this exemption, you need to document that the following conditions are fulfilled:

  1. The substance must have been registered before it was exported from the EU.
  2. The substance already registered and exported must be the same, as the substance being re-imported.
  3. The substance must not only be the same but it must actually proceed from the same supply chain in which the substance was registered.
  4. The re-importer must have been provided with information on the exported substance as required by REACH (e.g. safety data sheet).

For further information, see chapter 2.2.3.6 "Re-imported substance" in the Guidance on registration:

How do I document substances under customs supervision?

If substances are in temporary storage with a view to re-exportation and remain under customs supervision, they are not subject to REACH.

To rely on this exemption, you need to document that the following conditions are fulfilled:

  1. The substances are put in a free zone or free warehouse as defined under customs legislation or placed under another relevant customs procedure (transit procedure, temporary storage).
  2. The substances are kept under the supervision of the customs authorities.
  3. The substances do not undergo any form of treatment or processing during their stay in the EU. A free zone or a free warehouse in the EU territory is part of the EU.

For further information see chapter 2.2.2.2 "Substances under customs supervision" in the Guidance on registration:

What are some examples of articles containing substances intended to be released?

Substances may be intended to be released from articles to provide "added value". Scented children's toys, for example, are articles made with the intent of releasing substances. The release is an additional quality of the toy and is therefore intended because it gives added value, namely a pleasant smell.

As a counter-example, consider the case of a printer cartridge or a wet cleaning wipe. In these cases, the substances can be physically separated from the article. Therefore, they cannot be considered as substances in an article, but rather as substances in a container.

The consequence is that the supplier of cartridges is considered as a supplier of substances and the general registration obligations therefore apply.

For further information see the Guidance on requirements for substances in articles:

How do I find out if the substance in my article has been registered for a use?

In most cases, if you want to find out for which uses a substance has been registered, you will have to ask other actors up your supply chain.

For this purpose, you need to describe the function of the substance in the article, the process by which the substance is included in the article and into which type of article. This description should be in line with the use descriptor system.

Safety data sheets (SDSs) can be helpful as they contain information on uses of the substance or mixture as far as they are known by the supplier. If the SDS also includes a registration number, it may be possible, depending on the accuracy of the use descriptions in the SDS, to conclude that a particular use of this substance has already been registered. However, if you have doubts, you should seek confirmation from the actual registrant up the supply chain.

Alternatively, you could identify and ask manufacturers or importers of that substance from any supply chain for the uses they have registered this substance for, or whether they have registered it for a particular use.

A good way to identify manufacturers and importers of a substance is to launch a corresponding request within the substance information exchange forum (SIEF) for this substance, provided that you have pre-registered the substance or joined the SIEF as a data holder.

For further information see the Guidance on requirements for substances in articles:

What are my duties as an only representative?

As an only representative, you are fully responsible and liable for fulfilling all obligations of importers for the substances you are responsible for. These do not only pertain to registration but also to all other obligations of importers under REACH. As an only representative, you need to register the imported quantities depending on the contractual arrangements with the ‘non-EU manufacturer'.

You can represent one or several ‘non-EU manufacturers'. If you act on behalf of several ‘non-EU manufacturers', you must submit a separate registration for each of these manufacturers.

Your registration dossier should contain all uses of the importers covered by the registration. You need to keep an up-to-date list of importers within the same supply chain of the ‘non-EU manufacturer' and the tonnage covered for each of them, as well as information on the supply of the latest update of the safety data sheet.

For further information see chapter 2.1.2.5 "Only representative of a non-EU manufacturer" in the Guidance on registration:

What do I need to do if I find my volume has exceeded 100 tonnes per year?

Each year, you need to calculate your yearly tonnage as the average over the three preceding years.

Example

If you have yearly volumes of 60 tonnes in 2013, 90 tonnes in 2014, 140 tonnes in 2015 and 200 tonnes in 2016. The three-year average tonnage in 2016 is 97 tonnes per year, but the three-year average in 2017 is 143 tonnes.

In this case, you would need to register the substance as soon as possible as the registration deadline for substances over 100 tonnes per year has passed on 31 May 2013. The registration requirements should be based on the 2017 tonnage calculated as the average over 2014-2016, i.e. 143 tonnes.

As the yearly tonnage is based on a three-year average it should be easier for companies to anticipate any increase of yearly tonnage.

For further information see the Guidance on registration:

How is a polymer defined under REACH?

A polymer is a substance consisting of molecules characterised by the sequence of one or more types of monomer unit. Such molecules must be distributed over a range of molecular weights. Differences in the molecular weight are primarily attributable to differences in the number of monomer units.

Under REACH, a polymer is defined as a substance meeting the following criteria:

  1. Over 50 percent of the weight consists of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant; and,
  2. The amount of molecules presenting the same molecular weight must be less than 50 percent of the weight.

For further information see chapter 2.2.3.7 of the Guidance on registration:

Full details on polymers are available in the Guidance for monomers and polymers:

Which substances are covered by Annex V?
Annex V of REACH lists thirteen broad categories of substances for which registration is deemed inappropriate or unnecessary. The registration exemption applies to the substances as such, provided however that they meet the conditions for the exemption which are given in the particular category of Annex V.
 
If you need more detailed information on any category of substances, you can find this in the Guidance for Annex V, which gives explanations and background information for applying the different exemptions and clarifies when an exemption can be applied and when not.
 
Which substances are exempted from registration in the interest of defence?

In specific cases, REACH allows individual Member States to exempt certain substances from the application of REACH, in the interests of defence.

More information on national exemptions in the interest of defence in individual Member States is available on the European Defence Agency website:

How is a non-isolated intermediate defined under REACH?

A non-isolated intermediate is defined as an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place.

For further information see the Guidance on registration:

Which substances used in food or feedingstuffs are exempted from registration?

When a substance is used in food for humans or feedingstuffs for animals in accordance with the Food Safety Regulation ((EC) No 178/2002), the substance does not have to be registered.

This includes the use of the substance:

  • as a food additive in foodstuffs (Council Directive 89/107/ECC);
  • as a flavouring in foodstuffs (Council Directive 88/388/ECC and Commission Decision 1999/217/EC);
  • as an additive in feedingstuffs (Regulation (EC) No 1831/2003);
  • in animal nutrition (Council Directive 82/471/EEC).

Amounts of the same substance used for other uses than food and feedingstuffs are not exempted from registration. Only the amounts of the substance used in food and feedingstuffs are exempted from the registration obligation under REACH.

For further information, see chapter 2.2.3.1 of the Guidance on registration:

Which substances used in medicinal products are exempted from registration?

When a substance is used in a medicinal product within the scope of either:

  • The Regulation on Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency ((EC) No 726/2004); or
  • The Directive on the Community code relating to veterinary medicinal Products (2001/82/EC); or
  • The Directive on the Community code for medicinal products for human use (2001/83/EC); the substance does not have to be registered under REACH for that use.

The exemption does not distinguish between active or non-active ingredients as it applies to any substance ‘used in medicinal products'. Excipients used in medicinal products are therefore also exempted from registration.

Amounts of the same substance used for other uses than pharmaceuticals are not exempted. Only the amounts of the substance used in medicinal products are exempted from the registration obligation.

For further information, see chapter 2.2.3.2 of the Guidance on registration:

Which substances used in biocidal products are regarded as registered?

Active substances manufactured or imported for use in biocidal products are regarded as registered for the use in that biocidal product in the following situations:

  • The active substance has been approved in accordance with Regulation (EU) No 528/2012 ("BPR"), or
  • The active substance is under assessment in the review programme of existing active substances established under Article 16(2) of Directive 98/8/EC and continued under Article 89 BPR.

The list of approved active substances is available from the ECHA website:

To check which active substances are in the review programme, please see Annex II, part I to Commission Delegated Regulation (EU) No 1062/2014, also available from the ECHA website:

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

An exemption from REACH registration also applies in the following cases:

  • The active substance is manufactured/imported for use in a biocidal product which has a simplified authorisation (Article 27 BPR)
  • The active substance is manufactured/imported for use in a biocidal product which has a provisional authorisation (Article 55 BPR)
  • The active substance is manufactured/imported for use exclusively in a biocidal product which is the subject of experiments or tests for the purposes of scientific or product and process-orientated research and development (Article 56 BPR).

If you manufacture or import a substance for biocidal and non-biocidal uses, you need to register it for the quantities of the substance used in non-biocidal products.

Which substances used in plant protection products are regarded as registered?

Active substances manufactured or imported for use in plant protection products, in accordance with Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market, are regarded as registered under REACH (for that use) if the active substance is approved and included in Commission Implementing Regulation (EU) No 540/2011 (list of approved active substances), or where the application for approval of the active substance is deemed admissible in accordance with Article 9 of Regulation (EC) No 1107/2009.

Amounts of the same active substance used for other uses than in plant protection products are not regarded as being registered even if they are approved. Also, other substances such as co-formulants, synergists, safeners and adjuvants are not regarded as being registered.

The Commission maintains an electronic list of the approved (and non-approved) active substances which is available at the following link:

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

When should a recovered substance be registered?

A recovered substance should be registered as soon as it is no longer considered waste (when it reaches the end of waste criteria).

For further information on the end of waste criteria, see the following page:

How do I document that a recovered substance is already registered?

To benefit from this exemption, you need to document that the following conditions apply:

  1. The same substance must have been registered.
  2. The substance must be the same.
  3. The company that did the recovery must have the information required by REACH available (e.g. safety data sheet).

For further information, see chapter 2.2.3.5 ‘Recovered substance already registered' in the Guidance on registration:

Which substances are covered by Annex IV?
Annex IV of REACH lists a number of substances for which sufficient information is available to consider them as causing minimum risk to human health and the environment.
 
These substances are typically of natural origin and the list of exempted substances includes, for example, water and nitrogen. Substances included in Annex IV are exempted from the registration provisions.
 
The registration exemption applies to the substance as such, not to a particular use.
 
For more information see Annex IV of the REACH Regulation:
 
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).