We received a lot of questions following our recent REACH Webinar. Our presenter, Carlos Miguel Fazendeiro, took the time to answer each of them. We have gathered all the answers below. If you have additional questions, please email us at email@example.com.
Want to watch the webinar? Click here for the on-demand version: http://www.workcast.com/?pak=7182697357777640.
Who can be appointed as an Only Representative? Can I ask my consultants in Europe to act as my OR?
Firstly, only a non-European Manufacturer may appoint an Only Representative in the EU, a distributor or sales agent cannot.
If you are a manufacturer, you can ask the consultancy firm you work with to act as an OR as long as the company complies with Article 8:
An OR should also comply with the best practices recommended by the Only Representatives Organisation (ORO).
If my manufacturer registers a substance I use, does this registration cover me?
We need to consider two situations:
- Manufacturer located outside the European Union: The manufacturer may decide to register by appointing an OR, necessary to guarantee that the quantities to be imported into the EU are covered by the registration tonnage band. However, the manufacturer can also decide not to register or the total quantities imported may not be covered by the registration. The client will then become an importer with registration obligations.
- Manufacturer located in the European Union: It is mandatory for the manufacturer to register in the applicable tonnage band in order to produce and place substances on the market. The client will become a downstream user with no registration obligation.
Remark: To be able to fully answer this question, it is also necessary to verify whether the registration will be done as intermediate or full substance and whether the uses will be covered in the dossier.
When a company is engaged in a joint registration, will additional requests from ECHA beyond the 2018 deadline be fulfilled jointly or by each company individually?
This depends on the type of additional information requested.
If the additional requests concern the section 2, or sections 4 to 7 of the lead dossier (additional data required, example read-across or waiving not accepted) or the joint CSR, then additional costs need to be shared equally and the updates must be submitted by the Lead Registrants.
If the requests relate to a company’s own CS d R, uses, substance composition (missing spectral/analytical data or low quality of data) or even not in compliance with the boundary composition defined by the lead registrant, then additional requests and their associated costs are the responsibility of each company.
Once approved by ECHA, are registrations time-limited?
No, registrations are not time-limited. The requirement however is that, unlike authorizations which are provided for a certain period and require renewal, registrations must be kept up-to-date. Updates may regard tonnage that may be exceeded, administrative data, new uses, new data on substance properties and classification.
During the Stakeholder’s Day in Helsinki last May, ECHA mentioned that a dossier is considered unreliable if it is not updated after 5/6 years.
In case of intermediate for which no data has ever been generated, which studies should be launched for CLP aims? Is it mandatory?
This has to be evaluated by a toxicologist depending on the substance. It’s not mandatory but recommended if there is no information available that could confirm or allow to establish a classification and labelling. In case of transported isolated intermediates in quantities above 1000 ton/year, Annex VII studies are mandatory.
If a company has a material which was not developed or introduced during the REACH Pre-registration era, what happens to this materials? Do the same deadlines apply?
In the case of a non-phase in substance, it is necessary to submit an inquiry dossier to ECHA as only phase-in substances can benefit from pre-registration. However, after the 31 May 2018 deadline, both phase in and non-phase in substances will require an inquiry and registration to be submitted prior any manufacturing or importing above 1 ton.
Are there specific requirements for businesses located outside of the EU that are supplying chemicals on the REACH list to companies within the EU?
A non-EU manufacturer has 2 choices:
- Appoint an Only Representative (OR) in the European Union to take over the registration of the substances. In this case, the EU clients/importers will not have to register as they will be covered under the umbrella of the OR.
- Export to the European Union having the importers registering by themselves the substances as such or in mixtures. It is important to know that most importers do not like this approach and prefer to buy from non-EU suppliers that have appointed an OR.
Can REACH data be used outside the EU?
REACH data can be used globally by the data holder but only if the quality is sufficient (testing done under GLP) and in accordance with the requirements of other non-EU countries.
Companies that do not own the data but have only purchased a Letter of Access need to check if it includes the use in other jurisdictions. In most cases this does not happen and additional payments may be necessary.
How does a EU buyer handle the importation of a petroleum product that arrives at discharge port meeting the required physical specification but has a CAS number that he has not registered? Can he physically discharge? Can he reclassify the product using the CONCAWE shortlist?
If the importer has a registration for a specific CAS and is importing a substance with a different CAS number, this would not be covered by the registration.
However, if you can prove through testing that the substances are the same, then it would be necessary to agree with the non-EU supplier to change the CAS number accordingly. Otherwise, problems with customs and authorities would arise.