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REACH registration guide

Who has to register substances?

Only a natural or legal person established within the Community can be a registrant. Registration must take place when this person:
(1) manufactures a substance within the Community,
(2) is responsible for import into the Community or
(3) has been appointed as an only representative according to Article 8 of the REACH Regulation.

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

It is very important that companies correctly identify their role (or roles) in the supply chain for each substance they handle, because this will be a decisive factor in determining their registration obligations.

Please note that non-Community companies that are not established within the Community do not have direct obligations under REACH. It is the importer established within the Community that needs to comply with the obligations of REACH. However, to relieve the importers of their obligations, the company not established within the Community may decide to appoint an “only representative”

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Which substances have to be registered?

Registration is required for all substances:
  • as defined in Article 3 (1) of the REACH Regulation;
  • manufactured in or imported into the Community in quantities of 1 tonne or more per registrant per year;
  • unless they are explicitly exempted from the scope of registration according to Article 2 (1) to (3) and Annexes IV and V or partially exempted according to Article 2 (5-9) of the REACH Regulation;
  • irrespective of whether they are classified as dangerous or not.

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When do I have to register my substances?

Various aspects need to be taken into account when thinking of the registration deadlines. These include tonnage, dangerous properties, or whether it is a phase in or a non-phase in substance. Chapter 1.7 of the Guidance on Registration (Section 1.7.1.1 – phase-in substances) provides information on this matter.
  • The REACH Regulation creates a special transition regime for phase-in substances (Section 1.7.1.1 – phase-in substances). In order to benefit from the extended registration deadlines for phase-in substances (Section 1.7.2 – deadlines for registration), these substances must be pre-registered between 1 June 2008 and 1 December 2008. Depending on the intrinsic properties of the substance, along with its tonnage, it will then need to be registered by 1st December 2010, 1st June 2013 or 1st June 2018.

  • Phase in substances which have not been pre-registered must be registered before manufacture or import can continue. Therefore, if a phase-in substance is not pre-registered it should be registered if a company wishes to continue to manufacture or import. 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 the Agency regarding any previous registration for that substance.

  • Non-phase in substances must be registered before they can be manufactured or imported. This obligation will start on 1st June 2008. Prior to registration of such substances, the manufacturer or importer has a duty to make an inquiry to the Agency regarding any previous registration for that substance.

  • Within six months after first manufacture or import above the one-tonne threshold, and no later than 12 months before the relevant deadline for registration in the case of a first-time manufacture or import after the pre-registration deadline (1 December 2008) has passed.

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How much is the registration fee?

Article 74 of the REACH Regulation lays down the basic provisions on the requirements for fees. The fees are specified in a Commission Regulation No. 340/2008 on fees and charges payable to the ECHA. However, a fee is not required for the registration of substances in a quantity of between 1 and 10 tonnes per year for which a registration dossier containing the full information in Annex VII to the REACH Regulation is submitted. A reduced fee is set for SMEs. For more information please visit:
http://www.reachor.com/SME.html

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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 the Guidance on Registration (Section 1.6.2 – Calculation of volume to be registered).

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Do I have to register alloys?

Alloys are regarded as preparations according to Article 3 (2) of the REACH Regulation. This implies that only the single chemical elements in the alloys have to be registered but not the alloys itself.

The Guidance on Registration (Section 1.4 – on definitions) provides further information on the definition of a preparation and the distinction between a preparation and a multi-constituent substance. Guidance shall be developed for preparations, including assessment of substances incorporated into special preparations, such as metals incorporated in alloys (see also Recital 31 of the REACH Regulation).

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Do I have to register intermediates?

According to Article 3 (15) of the REACH Regulation, an intermediate is defined as a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance(s). Therefore an intermediate should not be present in the final manufactured substance (except as an impurity). It then depends under which type of intermediate as described in REACH your intermediate falls whether you have registration obligations. Different types of intermediates are defined under REACH:
  • Non-isolated intermediates
    For the use of a substance as a non-isolated intermediate, there are no obligations under REACH Regulation.
  • Isolated intermediates:
    • 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 6.3). 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).
    • 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 (see FAQ 6.3). 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). In this case, both the registrant and the users are each liable for their own statement regarding the strictly controlled conditions.
The specific Guidance on Intermediates describes when and how the specific provisions for the registration of intermediates under REACH can be used.

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Do I have to register a substance occurring in nature if I have to apply a process to extract this substance, e.g. extracting wool wax from wool fibres?

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 or classified as dangerous in accordance with Directive 67/548/EEC. For answering the question, if a process can be applied to extract such a substance without the need for registration, it has to be verified if 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.

Applied to the example above, there is at first sight no obligation to register wool wax as such, as it is a substance occurring in nature. To remove the wool wax from the wool fibre, a process may be applied that may include a treatment with detergents as wool wax is insoluble in water. When detergents are used during the process, the question is if the extracted wool wax can still be considered as a substance which occurs in nature. As mentioned, it has to be verified, if 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. If, for example, the wool wax is processed by using “flotation” which is a well defined process mentioned in Article 3(39) and may include treatment with detergents, the wool wax still can be regarded as a substance which occurs in nature. However, 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) is applicable or not.


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