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1. What is REACH and where do I find more information?
Ans: REACH stands for the Regulation for Registration, Evaluation, and Authorization And Restriction of Chemicals. The REACH Regulation entered into force on 1st June 2007 to streamline and improve the former legislative framework for Chemicals of the European Union (EU). REACH also creates the EuropeanChemicals Agency (ECHA) which has a central co-ordination and Implementation role in the overall process. ECHA is located in Helsinki, Finland and will manage the registration, evaluation, authorization and Restriction processes for chemical substances to ensure consistency acrossThe European Union.
2. What has been changed by the Corrigendum to REACH of 29 May 2007?
Ans: The objective of Corrigenda to REACH of 29 May 2007 was to rectify linguistic errors but not to make changes on the content of the text. Most of The changes should be applicable to language versions other than English. One change to be mentioned here is in Article 64 (8) where a printing error Has been corrected: the reference to the procedure to arrive at a final decision On granting or refusing the authorization has been corrected to Article 133(3), Being the regulatory committee procedure.
3. When does the REACH Regulation start to apply? (Revised)
Ans:Article 141 of the REACH Regulation provides the dates of entry into forceAnd application of the REACH obligations and provisions. On 1 June 2007, the REACH Regulation entered into force and those Provisions not mentioned in Article 141 (2) to (4) started to apply. On 1 June 2008, most of the main provisions started to apply, i.e. Title II on Registration, Title III on Data Sharing, Title V on Downstream Users, Title VI on Evaluation, Title VII on Authorization, Title XI on Classification and Labeling Inventory and Title XII on Information. Articles 128 on Free Movement and 136 on Transitional measures regarding existing substances. Title VIII and Annex XVII on Restrictions will apply from 1 June 2009.TOP
4. Is it necessary that labels on wiring harnesses have to appear in the IMDS breakdown?
Ans: In accordance with Articles 125 and 126 of the REACH Regulation, Member States are responsible for preparing national provisions defining controls and Sanctions for non-compliance of the REACH Regulation by 1 December 2008. We recommend that you contact the relevant enforcement authorities in your Country to learn about the national control procedures to be put in place. You May also contact the customs authorities and the RGBSI helpdesk for further Information.
5. Does REACH apply to substances (either on their own, in Preparations or in articles) manufactured or imported in Volumes below 1 tonne per year?
Ans:Yes, because there are several obligations under REACH. Registration Requirements only apply to substances that are manufactured or imported I Quantities of 1 tonne or more per year per registrant (see section 6 on registration). However if a substance is manufactured/imported at less than 1 tonne per year per registrant, other obligations under REACH may apply if the substance falls within the scope of REACH. These obligations also depend on the characteristics of the substance (e.g. is it classified as dangerous or not). In addition, obligations under REACH will differ depending on your role in relation to the substance (e.g. whether you import it or buy it from an EU manufacturer and use it).
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6. Do substances at nano-scale fall under the scope of REACH?
Ans: Yes and their health and environment properties must be assessed following the provisions of the REACH Regulation. Potential registrants should first consider whether they have obligations under REACH, irrespective of the size of the substances. Once it is established that the substance falls within the scope of REACH, further investigation of the detailed provisions of REACH may indicate that different provisions apply according to the hazard properties associated with the size of the substances. The evolving science of nanotechnology may necessitate further requirements in the future to reflect the particular properties of nano particles.
7. To which territories does REACH apply?
Ans: REACH is an European Community Regulation that directly applies in all Member States of the European Union. As REACH is of EEA (European Economic Area) relevance, Iceland, Liechtenstein and Norway will apply REACH after it has been incorporated into the agreement of European Economic Area. Substances imported in the Community from Switzerland (a non EU country belonging to EFTA (European Free Trade Association) but not to EEA) are treated under REACH in the same way as substances imported from any other non-EU country. Member States are best placed to explain how REACH applies to their territories (autonomic areas or overseas territories). We therefore recommend contact with the national helpdesk of the relevant country to clarify specific requirements.
8. What are the obligations of non-EU companies?
Ans: Non-Community manufacturers do not have direct obligations under the REACH Regulation. It is the importer established within the Community, who needs to comply with the REACH obligations.
According to Article 3 (9) of the REACH Regulation, a manufacturer means any natural or legal person established within the Community who manufactures a substance within the Community. Non EU companies exporting substances on their own, in preparations or in articles to the Community may (but are not obliged to) appoint an “only representative” according to Article 8 of the REACH Regulation to fulfil the obligations of importers. More guidance on only representatives can be found in the Guidance on Registration .
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9. How much is the pre-registration fee?
Ans: There is no fee for pre-registration. However according to Article 74 of the REACH Regulation that specifies the requirements for fees there will be a fee for registration. \
10. How is it possible to find out whether a substance is preregistered?
Ans: According to Article 28 (4) of the REACH Regulati o n , ECHA shall publish on its website the list of pre-registered substances by 1 January 2009. Downstream users of substances not appearing on this list of pre-registered substances may notify ECHA of their interest in these substances and provide their contact details and, if relevant, the contact details of their suppliers (Article 28 (5)).
REGISTRATION
11. Who has to register substances?
Ans: 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. More information on roles as a potential registrant can be found in Article 3 (7) to (11) of the REACH Regulation, in the Guidance on Registration
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12. In case of a multinational company, who is the registrant?
Ans: In the situation where a company group is composed of several natural or legal persons, each of those must determine if they qualify as registrants according to Article 3 (7) of the REACH Regulatio n . International companies sometimes have several daughter companies in the Community, often spread over several Member States. If these subsidiaries of the parent companies are separate legal entities to the parent company, (a natural or legal person as defined under applicable national law), then they, may be a registrant under REACH. Please see FAQ 6.1 on who has to register a substance.
13. Which substances have to be registered?
Registration is required for all substances:
If you want to know whether you have to register a substance you should first consult the Guidance on Registration (Section 1.6 – What to register). This guidance provides definitions, explanations and you will also find information on substances exempted from registration. In addition to the guidance, the use of the Navigator is recommended to find out whether you have any obligations under REACH for a given substance. The Navigator helps to clarify the registration obligations of your specific substance.
Do I have to register substances in articles?
The registration requirement under the REACH Regulation according to Article 7(1) applies to substances in articles for which all the following conditions are met:
- The substance is intended to be released during normal and reasonabl foreseeable conditions of use; and The total amount of the substance present in the articles exceeds one tonne per producer or importer per year the substance has not yet been registered for that specific use Notification is required for substances of very high concern (SVHC) present in articles under certain conditions.
14. Do I have to register alloys?
Ans: 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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15: Do I have to register chemically surface treated substances?
Ans: 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 preparation nor be defined by the criteria of the "Guidance for identification and naming of substances under 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.
16. When do I have to register my substances?
Ans: 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
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17. What are the requirements and procedures for new substances placed on the market before the registration obligations of REACH apply (1 June 2008)?
Ans: The placing on the market of new substances until 1 June 2008 is regulated by Directive 67/548/EEC on the Classification, Packaging and Labelling of Dangerous Substances, as amended by Directive 92/32/EEC. Thus if a new substance is placed on the market in quantities of 10 kg or more per year it has to be notified to the Competent Authority (CA) of the Member State where the substance is manufactured or where the notifier is established in case of a manufacturer located outside the Community. Please contact the relevant CA (Notification-Units) directly for further information on the notification procedure under Directive 67/548/EEC. Article 24 of the REACH Regulation provides that notifications according to Directive 67/548/EEC are regarded as registrations for the purposes of REACH. ECHA will assign a registration number to those notifications regarded as registrations by 1 December 2008. Please note that a notification under Directive 67/548/EC is nominal so that only the notifier benefits from his substance being considered as registered (see FAQ 6.3.6). The Guidance on Registration (Section 1.6.5.3 - Notified substances) provides further information on this issue. Transitional measures regarding requests to notifiers to provide further information on notified substances can be found in Article 135 of the REACH Regulation.
How to distinguish between intended and accidental release of a substance from an article? (NEW)
As a general rule, intended release relates to the function or quality of an article. The release of substances from articles is considered “intended” when it is essential for the end use function or “adds value” to the article.
Example: Release of perfume from a perfumed eraser (function = to erase, added value / function for convenience = quality of smelling good).
A release is not considered to be intended in the following cases:
● A release occurs during removal of ‘impurities’ from a semi-finished or finished article during its production process.
Example: A size is added to a fabric to improve its process ability. Sizes are released during further wet processing of the textile.
● A release occurs during use or maintenance of the article and is meant
to improve the product quality in a wide sense or the safety as a side effect but the released substances do not contribute to the function of the article.
Example: Washing of clothes by the consumer where remnants of different chemicals (dye, softener, starch etc.) from processing are removed over some washing cycles.
● A release of substances is an unavoidable side-effect of the functioning of the article. Examples: wear and tear of materials under conditions with high friction, e.g. break linings, tyres.
● A release of substances formed in a chemical reaction is an unavoidable side-effect of the functioning of the article
Examples: ozone released from copy machines.
● A release is incidental or caused by undue use. This also includes any form of misuse and inappropriate use which is not in accordance with the use instructions or functionality, even if it could have been anticipated
Examples: release of substances from a thermometer which drops and breaks.
For further details please consult the Guidance on Requirements for Substances in Articles.
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18. How do I calculate the tonnage?
Ans: 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).
19. How will the password change work because of new password length with IMDS Release 6.0?
The new password rules must be applied only with the next issued password change. Either latest after 90 days after the last change (because after 90 days the users must change their password) or when the user triggers a password change himself
20. How do I register my substances and do I need IUCLID 5?
Ans:All registrations shall be submitted to ECHA. REACH-IT provides an online company homepage to submit data to ECHA. For more information please visit the ECHA website at: http://echa.europa.eu/reachit_en.asp 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 5 is a software tool for companies to store data on chemicals and prepare for their registration to the ECHA. Registrants are not obliged to use the IUCLID system, but they must submit their registration in the IUCLID format. The IUCLID 5 software is downloadable free of charge from the IUCLID website .
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21. How much is the registration fee?
Ans: 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 we kindly advice you to consult the European Commission website: http://ec.europa.eu/enterprise/reach/reach_fees_en.htm
22. Who can appoint an only representative?
Ans: According to Article 8 (1) of the REACH Regulation, a legal or natural person that manufactures a substances (to be used on its own, in preparations and/or to produce articles), formulates preparations or, if the substances in their articles are required to be registered, produces articles, outside of the EU can nominate an only representative located within the EU to carry out the required registration of their substances that are imported into the Community. The only representative will have to fulfil the registration obligations of importers (Title II of REACH) and comply with all other obligations of importers under the REACH Regulation. More information on the only representative is provided in the Guidance on Registration
23. How can I identify a third party representative when pre-registering?
Ans:Third Party Representative (TPR) that acts on behalf of the potential registrant’s company for the data sharing process related to this substance needs to:
· Acting as a TPR, sign up as TPR first and separately to obtain his unique identifier UUID “Universally Unique Identification” online in REACH-IT.
· In order to be selected as TPR by the registrants when he/she pre-registers, the TPR must communicate his/her UUID to the potential registrants he/she will work on behalf of the potential registrants.
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24. Is there a special procedure to establish an only representative?
Ans: The issue of becoming an only representative is a question of mutual agreement between the “non-Community manufacturer” and the natural or legal person established in the European Community who is being appointed as an only representative. When the only representative submits the registration(s) he is advised to submit copy(-ies) of the letter(s) officially assigning him. More information on the duties of the only representative is
provided in the Guidance on Registration (Section 1.5.3.4 – Only representatives of “non-Community manufacturer”). The “non-Community manufacturer” shall inform the importer(s) within thesame supply chain of the appointment of the only representative according to Article 8 (3) of the REACH Regulation. These importers shall be regarded as downstream users.
25. Can an only representative represent more than one company?
Yes, an only representative can represent one or several non-EU companies that manufacture substances, formulate preparations or produces articles exporting to the Community, even for the same substance. More information on the duties of the only representative is provided in the Guidance on Registration (Section 1.5.3.4 – Only representatives of “non-Community manufacturer”).
26. Can a third party representative register?
No. According to Article 4 of the REACH Regulation a manufacturer, importer or downstream user may appoint a third party representative for all,proceedings under Article 11, 19, Title III (Data sharing and unnecessarytesting) and Article 53 of the REACH Regulation involving discussions withother manufacturers, importers or, where relevant, downstream users. Thisappointment is for the purpose of joint submission of data for registration and data sharing and enables the registrant to remain anonymous when negotiating with other parties, in particular within a SIEF. Unlike an Only Representative, a third party representative only plays a part in the negotiations between the (potential) registrants, while the individual registrant retains full responsibility for complying with his obligations under the REACH Regulation. [Note that this answer refers to a “third party representative” in the meaning of Article 4 of the REACH Regulation. “Third parties” in a general sense (e.g. consultants working on behalf of a company) can of course do work under normal commercial arrangements as for any other activity.] |
