The REACH Regulation (EC 1907/2006) imposes the Registration, Evaluation and Authorization of manufactured Chemicals that are imported or used within the European market. The regulation aims to rationalize and improve the regulatory framework concerning chemical matters.
Pre-requirements : some key notions
REACH registration
If you manufacture or import your substances between 1 and 100 tonnes a year, you are directly concerned by REACH and have to elaborate and submit your registration dossier before 2018. Click here to find out more about registration.
The SIEF
Once a substance has been pre-registered, co-declarants join a Data Sharing and Substance Information Exchange Forum (SIEF). One of the objectives of the SIEF is to limit animal testing while encouraging manufacturers and importers of substances to share costs.
The Letter of Access
A Letter of Access (LoA) is a document that grants you the right to refer to the Lead Registrant’s (LR’s) registration dossier.
IUCLID
IUCLID (International Uniform Chemical Information Database) is a free software developed by ECHA and the OECD in 2007. The software plays a central role in the IT environments of all organizations that have to cope with the data submission requirements of REACH.
Member registrant
Member Registrants (MRs) have to submit dossiers with the specific information of their company and substance (for instance the substance profile, the substance use and the production volume). Member Registrants are not obliged to submit information that has already been presented in the Lead Registrant’s dossier.
Lead registrant
Members of a SIEF have to appoint a Lead Registrant (LR) who will act on behalf of them. The Lead Registrant has to prepare the principal dossier of the joint submission gathering data on the substance and its uses: physiochemical, toxicological and eco-toxicological properties.
CHESAR
CHESAR (Chemical Safety Assessment and Reporting Tool) is an application developed by ECHA to help companies carry out their chemical safety assessments and prepare their chemical safety reports and exposure scenarios for communication in the supply chain.
REACH-IT
REACH-IT is the central IT system that supports companies and ECHA to securely submit, process and manage data and dossiers. The platform provides a secure communication channel between both parties to help them coordinate the processing and evaluation of data and dossiers.
7 steps to create your registration dossier
The first two waves of registration have shown that the process is quite long and can take more time than primarily expected. EcoMundo would like to present the 7 key steps to successfully create your registration dossier.
Source: ECHA.
1) Identify your substances
- Prior to any registration, you have to evaluate the tonnage of your substance and the situation of your company. As part of the evaluation, you have to define which are the substances that have been manufactured or imported at more than 1 tonne per year on the European market (calculate the average tonnage for the three last years).
- EcoMundo tip: Do not hesitate to get all information you can from SDS, analysis certificates and any other documents. It will help you to save time on the long run.
- Regarding the substance itself, do not forget to verify if it is exempted from the REACH registration (REACH exemptions are defined by REACH Regulation 1907/2006 in Article 2).
2) Find registrants who have the same substance
2° A Lead Registrant has already been appointed: If SIEF members have already appointed a Lead Registrant; you have to get in contact with him/her in order to sign the SIEF agreement. Signing the SIEF agreement will give you the right to purchase the Letter of Access which gives you access to the information of the principal dossier. Once you have paid the Letter of Access fees, the Lead Registrant will send you by email both the joint submission dossier references and the token (for your information, the token is a password). These pieces of information will allow you to enter the joint submission on the REACH-IT platform.
- Check the creation of any other REACH-IT account. If there is no other account, then you must create one on the REACH-it platform (fill in your address, the size of your company, your contact and so on).
- Pre-registration is mandatory in the registration process. Indeed, pre-registration will give you a number that is absolutely necessary for your registration dossier. Thus, you may want to check if your substance has been pre-registered. If you find no evidence of any pre-registration, you must opt for a late pre-registration or an inquiry process. The inquiry process intervenes when you have missed the late pre-registration deadline or if your substance is completely new on the market.
- Once you have your pre-registration/late pre-registration/inquiry number, you may start the registration process. Click here to find out the differences between the three pre-registration processes.
- As a registrant of your substance, you will join a SIEF (Substance Information Exchange Forum). There is only one SIEF for each substance. Joining a pre-SIEF will give you the opportunity to evaluate the registration situation and adapt your strategy according to three different scenarios:
3) Make sure to organize yourselves within the SIEF
- The Lead Registrant acts on behalf of the other Member Registrants and has to be the first one to submit the dossier in order to allow the other registrants to have access to it. Member Registrants have to purchase a Letter of Access from the Lead Registrant in order to have the right to refer to the data of the joint submission and to add some specific information about their activity and substance.
- You may find below a recap of the documents you should add to your dossier:
4) Assess the risks
- Whether you act as a Lead or Member Registrant, do not forget to check the analytical data of your substance.
- EcoMundo tip :If you have followed our first tip (cf. step 1), you have anticipated the tests by gathering some upstream information about the substance. The anticipation of the laboratory tests will save you valuable time. Indeed, these laboratories are often booked up by demands and you might wait longer than expected (at least 2 months).
5) Use IUCLID 6 to prepare your registration dossier
- Once all your analytical data have been collected, you have to aggregate them into the IUCLID 6 software. The registration dossier is extracted from the software and forwarded to the REACH-IT platform where ECHA checks that all fields have been completed.
6) Submit your registration dossier
- ECHA will issue an individual invoice that you must settle within 2 months through bank transfer. If you do not achieve to pay the invoice within 2 months, you have to submit your registration dossier again and the registration fees are payable
- Once you settled your invoice, you may find a document with a registration number on your REACH-IT account. This document proves that you have registered and that your substance is compliant with the REACH Regulation.
7) Keep your registration dossier updated
- Registration requires a continuous update of your substance especially information regarding tonnage.
Lead Registrant or Member Registrant, which status should I choose ?
Lead Registrant: his/her specific role in the REACH registration
Considering the fact that the Lead Registrant acts on behalf of other registrants, he/she has a specific role in the registration process.
- The Lead Registrant has to carry out a data-gap. A data-gap is a research of toxicological and eco-toxicological data (on the substance) available and issued less than 12 years ago. The data gap usually gives available and useful information on the product. As part of this approach, Lead Registrants and Member Registrants exchange information. Lead Registrant can purchase or negotiate some information from the Member Registrants. All in all, the data-gap gives indications on the tests that the Lead Registrant has to conduct.
- EcoMundo tip : If you are the Lead Registrant of your SIEF, you should start the toxicological and eco-toxicological tests as soon as you can.
- The Lead Registrant is the one who manages the arrival of new Member Registrants in the SIEF. Managing the SIEF includes: writing and negotiating the SIEF agreement, issuing invoices for the Letters of Access and sending the tokens to the Member Registrants. Warning ! Please bear in mind that these responsibilities are very time consuming.
The advantages of being Lead Registrant
Although being Lead Registrant is time consuming, it will give you a considerable advantage on the long run: since you are in charge of the SIEF, you will be able to complete your registration faster. Furthermore, being Lead Registrant will also give you the opportunity to conduct the toxicological and eco-toxicological tests according to your criteria. Thus, you can create the Substance Identification Profile (SIP) and make sure that the tests concern your substance and its classification. All these factors may give you a strategic advantage over other companies that are part of the same SIEF.
Member registrant: his/her specific role in the REACH registration
As the Member Registrant purchases his/her access to the common part through the Letter of Access, he/she has some different roles in the joint submission.
- The Member Registrant checks if he/she has any specific toxicological and/or eco-toxicological data for his/her substance and decides whether or not he/she wants to share them.
- By signing the SIEF agreement, the Member Registrant can purchase the Letter of Access and enter the SIEF.
- The Letter of Access gives the Member Registrant access to the SIEF and allows him/her to refer to the Lead Registrant’s dossier.
The ultimate elements to bear in mind before strating your REACH registration
What are the different deadlines?
If you are the Lead Registrant, you have to submit your dossier as soon as possible in order to give some time to the Member Registrants to join your SIEF. The deadline set by ECHA is March 2018.
If you are a Member Registrant, the deadline set by ECHA is the 31st of May of 2018 (at 23:59).
For the late pre-registration, the deadline is the 31st of May of 2017. After this date, you will have to consider the inquiry process.
What are the fees and costs of the registration ?
There are different types of costs related to the REACH registration process: the common part fees, the individual part fees and the ECHA fees.
The fees related to the common and individual part of the dossier can vary according to your situation and role in the SIEF (Lead Registrant or Member Registrant).
The ECHA fees vary according to the tonnage of your substance and the size of your company.
Ecomundo tip : If you are an SME, please bear in mind that the European Commission grants discount percentages according to the size of your structure as follows:
- 30% for medium-sized companies
- 60% for small businesses
- 90% for micro businesses.
Click here if you want to read our article about the costs and fees of the registration dossier.
The importance of choosing a well-adapted strategy
Registering your substance is a long and complex process that requires several steps. It is important to establish a submission strategy that fits the specificity of your situation. Whether you choose to be Lead Registrant or Member Registrant, managing or joining a SIEF takes time. Thus, it is often better to use the services of specialized providers who can act on your behalf. The provider can give you some guidance on your strategic issues; can find laboratories to run the analytical tests and complete/submit your IUCLID 6 dossier.
EcoMundo advice
If you are Lead Registrant, we advise you to run your analytical tests by July 2017 at the latest.
If you are Member Registrant, you have more time to prepare all of your procedures (SIEF agreement, LoA and token) and to run your analytical tests. We advise you to start by September 2017 at the latest.
Check our REACH registration services for 2018
EcoMundo is an expert service provider for REACH registration 2018 Our services include:
- REACH compliance Service
- REACH consulting Service
- REACH for non-EU manufacturer
- REACH Registration
- Only Representative (OR) service
- REACH Late pre-registration and inquiry process
- Representation of your interests within the SIEF and/or consortium.
- Negotiation on your behalf and purchase of the Letter of Access (LoA) from the Lead Registrant
- REACH letter of access
- Data exchange and drafting of your REACH IUCLID dossier.
- Submission of your REACH dossier to ECHA and follow-up until acceptance
- Delivery of your REACH certificate
- Regulatory watch when needed
