REACH FAQ

• Can I still apply?

Pre-registration was only for companies planning to register phase-in (existing) substances. The main pre-registration period was between 1 June and 1 December 2008 allowing potential registrants of the same substance to establish contact to agree on the sameness of their substance, form a substance information exchange forum (SIEF), share data and submit a registration dossier jointly.

Companies starting to manufacture or import a phase-in substance in amounts of one tonne per year or more after 1 December 2008 were able to submit a late pre-registration and still benefit from the extended deadlines.

Following the last deadline (May 2018) potential registrants now need to submit an inquiry to ECHA before registering.

Our helpdesk can support companies in fulfilling their registration obligations or we can put you through our Matchmaker service.

• We need to register an intermediate which is both a transported and an on-site isolated intermediate. Will ECHA charge two fees, one for each type?

Yes. Even though dossiers for both intermediate and non-intermediate use or different types of intermediate uses can be submitted to ECHA in one submission, ECHA still considers these as separate registrations under REACH. In accordance with Articles 11(4), 17(2) and 18(2) of the REACH Regulation this triggers separate fees.

• What is a Letter of Access and what do I get for my money?

Under articles 25, 27 and 30 of REACH, registrants are obliged to share data on animal testing, when submitting their registration dossier. For both phase-in and non-phase-in substances, the section of the registration dossier on animal testing must be submitted jointly by the applicant. 

Registrants may have two options when submitting their joint registration. They can purchase a Letter of Access (LoA) or join the REACH consortium for that substance, which would give them access to the data for the purposes of registration. A letter of access (LoA) allows reference to be made to the joint registration dossier as applicable to them and as stated in the SIEF Agreement.  For example, a LoA would normally grant permission to use/ refer to a single/set of study(ies) by a data owner OR allow a SIEF member to refer to the entire Joint Submission for a certain tonnage band.

The LoA entitles registrants to refer to the information submitted to ECHA by the Lead Registrant for purposes of REACH registration, but it does not grant any additional rights except when specifically stated in the SIEF agreement.  In particular, the LoA cannot be used, or transferred or relied upon, either for REACH or for any other purpose, by other legal entities,  unless those other legal entities would qualify for a free update of the original registration(s) pursuant to Article 5 (1) (c) of Commission Regulation (EC) No 340/2008.

Once a LoA is granted the potential registrant should be given the data end-points agreed upon together with a robust summary of the study data (dependent on SIEF agreement), an html or i6z file of the IUCLID 6 dossier, minus Sections 1 and 3 (your personal sections) as well as a token. The token has a 30-day validity and comprises a string of letters and numbers generated by the Lead Registrant in REACH-IT. Co-registrants use the token in REACH-IT to confirm their membership of the joint submission. There is no need to attach the LoA to the IUCLID registration dossier unless you wish to. It is sufficient to make a statement that you, the registrant, have permission to refer to the data via a LoA. The LoA however, will be useful for enforcement purposes.

If you need help putting together a registration dossier or negotiating the price of a LoA, why not ask us to put you in touch with trusted service providers through our free Matchmaker programme? Contact us to find out more.

• We pre-registered a substance in the past but then stopped manufacturing it. We want to start manufacturing again but the registration deadline has passed. Do we need to submit an Inquiry dossier to ECHA?

The transitional regime envisaged by REACH came to an end in June 2018. The European Commission set 31 December 2019 as the cut-off date after which the rules for phase-in substances no longer applied. As the cut-off date has passed, Old pre-registrations cannot be used anymore and those potential registrants who did pre-register in the past need to first submit an inquiry to ECHA in order to begin data-sharing negotiations. 

• Can we continue to use the ‘three-year average’ rule for the tonnage calculation of phase-in substances?

The tonnage calculation for phase-in substances under the “3-year average rule” has ceased to exist and the “calendar year” calculation must be used. This means, in practice, that when a company estimates that they will reach in a calendar year the one tonne threshold of volumes manufactured or imported, they will need to register in that year, before they actually reach that threshold. If a company has registered a substance, the annual volume is calculated per calendar year. This is important to keep in mind for example if the company needs to update their registration to a higher tonnage band.

• How can a non-EU supplier ensure his EU customers can continue to use an Annex XIV substance after the sunset date?

   A non-EU supplier may support each EU/EEA importer directly with their applications for Authorisation. Alternatively non-EU manufacturers may choose to appoint an Only Representative to carry out the duties on behalf of the EU/EEA importing customers. The European Commission services have stated that the OR of a non-EU manufacturer is entitled to submit an application for Authorisation.

• We use an Annex XIV substance as an intermediate. Must it be used under Strictly Controlled Conditions to qualify for the exemption from Authorisation?

  Intermediates as defined are exempt from authorisation; neither the definition of an intermediate in Article 3 (15) of REACH nor the exemption in Article 2 (8) mentions strictly controlled conditions.

• Our supplier of an Annex XIV substance is not applying for Authorisation. As a Downstream User can we apply for authorisation so that they can continue to supply the substance to us?

   If a downstream user is granted authorisation to use an Annex XIV substance the supply of that substance to them by their immediate supplier will also be covered, irrespective of whether the supplier has applied for authorisation for that particular use.

• We import some chemicals for our own use on-site. Do we need to prepare Safety Data Sheets for these chemicals given that we do not supply them to other legal entities?

   REACHReady understands this question was discussed at HelpNet, the network of Member State national helpdesks, and that the conclusion was that REACH-compliant safety data sheets must be prepared. The reasoning is found in the following parts of the legal text:

   - Article 3 (32) defines supplier as “any… importer… placing on the market a substance, on its own or in a mixture, or a mixture”.

  - In Article 3 (12), the definition of placing on the market  states that “Import shall be deemed to be placing on the market”.

   Therefore, an importer is a supplier, even though it is supplying only to itself.

   - Article 31 (1) states “the supplier of a substance or mixture shall provide the recipient of the substance or mixture with a safety data sheet compiled in accordance with Annex II” (where the substance or mixture meets the SDS criteria in Article 31).

   Furthermore, Article 35 of REACH states that “workers and their representatives shall be granted access by their employer to the information provided in accordance with Articles 31 and 32 in relation to substances or mixtures that they use or may be exposed to in the course of their work”.

• We don’t need to register for REACH as our substances are less than one tonne per year. Does this mean we don’t have to update our Safety Data Sheets?

  The one tonne per year threshold in REACH applies to registration. The requirements for Safety Data Sheets are set out in a separate Title of the regulation and apply to the supply of chemicals at any quantity.

   If you are supplying a hazardous substance or mixture, a PBT or vPvB substance, or one that is otherwise included on the Candidate List, you must provide a SDS. When preparing a SDS you must ensure that it meets the requirements of REACH Annex II and subsequent amendments.

   Updating the SDS must be done ‘without delay’ in the following cases, as laid down in Article 31(9):

   - New information on hazard becomes available,

  - New information on risk management becomes available,

  - Once an authorisation has been granted or refused,

  - Once a restriction has been imposed.

   In updating your SDS you may find the information published on the ECHA dissemination portal useful, together with any other information available to you on the properties of the substance, its hazards or its uses.

   If you need to understand what REACH means for your SDS come along to one of our training events. Our Gold subscribers can also find out more via our Helpdesk and online technical guidance.

• Can we simply publish our Safety Data Sheets on our company website, or must we send them out to our customers?

   The duty to provide SDS is set out in Articles 31 and 32 of REACH. “Provide” is interpreted as positively sending the SDS to the recipient of the chemical, either by a hard copy or by an electronic copy as an attachment. Several Competent Authorities have indicated they will not accept the publication of a SDS on a company website as sufficient as it is merely making available rather than providing the SDS.

   As part of our Matchmaker service we can put you in touch with Approved Service Providers that offer secure delivery systems of electronic documents such as SDS. Contact us to find out more.

• My non-EU supplier’s Only Representative (OR) registered my substance and subsequent uses with the exception of one of my customer’s use. Should I stop supplying to that particular downstream user? Whose responsibility is it to ensure compliance?

   If your customer’s use is not covered, then as a downstream user they have the right to ask for the use to be considered. They should do this by sending you a request in writing to include their use. You will need to place a request to the OR for inclusion of the use. A decision will usually then be made by the OR and non-EU manufacturer (based on contractual agreements, commercial issues or health, safety and environmental reasons) on whether the use will be included. The final decision needs to be communicated back to your customer.

   If a decision is made to include the use, then the OR will have to update the registration dossier. If the substance is hazardous or a safety data sheet is otherwise mandatory the SDS must be updated without delay and given to the customer.

   If a decision is made to exclude the use for commercial reasons then you should stop selling for that use. The customer can only continue to use the substance if they have another supplier covering their use.

   If, once the use is assessed, the OR cannot include it due to reasons of human health or environmental protection the OR must inform both you and ECHA in writing. You need to pass this information to the customer, who has an obligation to notify ECHA within 6 months of receiving the registration number in a SDS. The customer may also need to prepare a Downstream User Chemical Safety Report within 12 months. Additionally, the OR must update the registration without undue delay to include the use as a “use advised against”.

• How does Article 33 apply to complex finished articles such as automotive vehicles in regard to the European Court of Justice Ruling on the interpretation of ‘article’?

   

   

  Where an article contains more than 0.1% by weight of a Candidate List substance its EU supplier must inform his business customers with the name of the substance as a minimum and information on safe use if necessary. Consumers are entitled to the same information within 45 days of a request. The ECJ ruling on the 10 September 2015 ruled in favour of the dissenting member states. The UK and the majority of member states had, previous to this date, taken the interpretation that an article is the finished product, a car for example, and so the identification of SVHCs was limited to the 0.1% w/w threshold with respect to the entire weight of the car. However, the court has ruled in favour of the ‘once an article, always an article’ interpretation, thus increasing the obligations on producers, importers and suppliers of articles as now each constituent article within the car (gear stick, steering wheel etc) needs to be considered. This ruling affects the interpretation of Article 33 in that suppliers of articles must communicate information to professional customers about SVHC presence not only for the products they supply, but also for all the constituent articles they are made from. Information received regarding any articles acquired from actors upstream in the EU supply chain will need to be communicated. If the articles are imported, the importer will have to determine SVHCs in excess of 0.1% w/w themselves.

• What is the new interpretation of Article 7(2) after the ECJ ruling and how have my obligations changed? In a similar manner as Article 33 the notification duties to ECHA encompass constituent articles, rather just the finished product. A notification must be made if the total tonnage (can be aggregated across multiple articles) of an SVHC exceeds 1 tpy AND the SVHC is present in > 0.1% w/w. Importers of articles, particularly of complex products, are most affected by this ruling since they have to determine SVHCs in all the constituent articles they import, not just as part of the complete imported product. Producers of articles are also affected as the notification duty corresponds to all articles they produce, not just what is supplied.
• Can we import an article containing an SVHC on the Authorisation List or is the substance banned from the EU?

   The import of articles is not controlled by the Authorisation List in Annex XIV of REACH. Articles containing Annex XIV substances may be imported into the EU/EEA legally, provided that doing so would not cause a breach of any other control measures in place such as restrictions under Annex XVII of REACH. The importer may have to inform ECHA and/or their customers of the presence of such SVHC.

• As a non-EU producer of articles must I stop using Annex XIV substances by the “sunset date” if those articles will be supplied to EU customers?

  Authorisation does not control manufacturing or production processes outside the EU/EEA. It regulates only those uses, and placing on the market for those uses, that take place within the jurisdiction of REACH. The sunset dates in Annex XIV do not apply where an article is produced outside the EU/EEA, and those goods may continue to be imported.

   Substances are added to Annex XIV because of severe risks to humans and the environment during their use. Of course, the intrinsic properties of those substances do not change according to where they are used; non-EU users of these chemicals may substitute them for the purposes of their own human health and environmental protection – voluntarily, or in order to comply with their own domestic laws. 

  If you need to know more about managing Articles compliance, come along to our next training day.