What is the aim of REACH registration?
REACH stands for Registration, Evaluation and Authorization of Chemicals and also includes restrictions applicable to these substances.
The registration process is based on the concept: “no data, no market”. According to the European Chemical Agency called ECHA: “Companies are responsible for collecting information on the properties and uses of the substances they manufacture or import above one tonne a year. They also have to assess the hazards and potential risks presented by the substance.” Please note ECHA’s principle: “One substance = one registration”.
If you’re not yet compliant with the REACH regulation, exporting your products to the European market becomes tricky, not to say impossible in certain supply chains.
When does REACH apply?
The REACH registration process requires EU manufacturers and importers of chemicals to submit a registration dossier to ECHA when they place more than 1 metric tonne per year of a chemical on the EU market. The REACH dossier includes information on substances such as physical and chemical properties, effects on human health, effects on environment and the evaluations which prove the above statements .
REACH registration for non-EU companies
If you're a non-European manufacturer/exporter, and you want to market your chemicals (either on their own or contained in mixtures) on the European market, you can comply with REACH and take part in the registration process just like a European company by appointing an "Only Representative" (OR). The OR will make contact with the SIEF, the Lead Registrant or the Consortium of the substance to be registered, prepare the registration dossier and represent the interests of his client before the European authorities. The role of the OR is to ensure full REACH compliance and endorse all legal responsibilities on behalf of the non-EU company.
Who should I designate as my Only Representative?
- A natural person or a legal entity as long as physically based in the EU
- Equipped with sufficient knowledge with regards to chemicals
- A company that I trust enough to share sensitive data with
You cannot appoint an Only Representative (OR) if:
- You're a non-EU company acting as distributor in your supply chain (no handling of chemicals)
- Your only role is to act as a third party representative in data-sharing process of REACH
Please note that the REACH registration process is paperless since everything is done through the REACH-IT portal set up by ECHA. Note that this portal is accessible to EU companies and ORs only
Am I concerned by the REACH 2018 deadline?
Who must register?
- EU Companies that import or manufacture the product/ raw materials/substances into Europe can take part in the process
- Non-EU Companies that export chemicals to Europe through an Only Representative established in the EU
*chemicals on their own, in mixtures, raw materials or products
What must be registered?
All the chemicals that are placed on the EU market above 1 tonne per year.
NB: You must not register the mixture itself nor the finished product but the chemicals that are contained in them. The chemical to be registered can be a substance on its own, or can be a substance found in a raw material or found in a finished formula, e.g. a paint.
You're not concerned if you meet one of these exemptions:
- Polymer substances as defined under REACH (Monomers need to be registered)
- Substance covered by Annex V of REACH
- Substances included in Annex IV of REACH
- Radioactive substances (EURATOM regulation)
- Substances covered by national exemption in the interest of defense
Or, if you use the following substances as mentioned
- Non-isolated intermediates that during synthesis are not intentionally removed from the equipment (except for sampling)
- Substances used for product and process orientated research and development (PPORD): these substances are exempt from registration for five years (extention possible), if you notify your PPORD activities to ECHA.
- Substances used in food or feedstuffs (including uses as additives or flavorings)
- Substances (active substances or excipients) used in medicinal products for human or veterinary use
- Active substances used in biocidal products or plan protection products.These are considered as already registered
The following substances don't need to be registered:
- Re-imported substances already registered
- Substances under customs supervision, destined for re-exportation.
- Waste: substances discarded as waste Framework Directive
- Recovered substances already registered
Which documents will I need for the REACH registration technical dossier
The technical dossier must contain information about:
- The identity of the substance
- Information on the manufacture and use of the substance
- The classification and labeling of the substance
- Guidance on its safe use
- (Robust) study summaries of the information on the intrinsic properties
- Proposals for further testing if relevant
- For substances registered in quantities between one and ten tonnes, the dossier also contains exposure related information for the substances (main use, categories, types of uses, significant routes of exposure)
A chemical safety Report,
- Summary of information on environmental and human health hazard of the substance
- Assessment of exposure and risk (when is required)
ECHAs Fees for REACH registration
Article 74 of EC 1907/2006 REACH regulation defines fees and charges. The registration costs will depend on the tonnage of your substances but also on the size of your company. However, paragraph 2 of that article states: “A fee need not be paid for a registration of a substance in a quantity of between 1 and 10 tonnes where the registration dossier contains the full information in Annex VII.”
All fees are in euros (EUR)
NB: A registration must be within a joint submission when the same substance is manufactured or placed on the market by more than one company.
Individual submission Joint submission Fee for substances in a quantity of between 1 and 10 tonnes €1,739 €1,304 Fee for substances in a quantity of between 10 and 100 tonnes €4,674 €3,506 Fee for substances in a quantity between 100 and 1000 tonnes €12,501 €9,376 Fee for substances in quantities greater than 1 000 tonnes €33,699 €25,274
Please note that discounts exist for micro, small and medium enterprises (SMEs) during registration. The discount percentages granted by the European Commission according to the size of the structure are as follows:
- 30% for medium sized companies
- 60% for small businesses
- 90% for micro businesses
Also within a SIEF you will have to pay the Letter of Acess(LoA) to access the information collected by other members. These costs vary and depend on the size of the SIEF and the number of necessary studies. It is important to note that you only pay the fee for the required data of your own registration.
For more information, feel free to request a quote: contact@ecomundo.eu
How do I register under REACH?
The regulation provides three registration periods depending on the tonnage. 2018 is the third and last registration phase. It concerns lower tonnages ranging from 1 to 100 tonnes/year. Due to the low tonnage, mainly micro small and medium companies will be affected by the registration.
Until May 2017 you have two options:
Late pre-registration: should be done via REACH-IT portal
- It allows access to the SIEF
- It allows to benefit from the last transitional deadline
- It does not exempt from registration requirement
Registration
- It is mandatory for all substances manufactured and/or imported between 1 and 100 tonnes per year
- It is impossible for a substance that has not benefited from pre-registration to be manufactured and/or imported on the European market as the registration process is not done
- One substance = One registration
Passed this deadline, you may ask for an inquiry dossier instead of a late pre-registration
When do I need to register?
The registration process takes between a few weeks to a few months. EcoMundo’s experts recommend starting the registration procedure as soon as possible. Indeed, required assessments can take time over the normal period of examination of the application. Also, each year the Lead Registrant can increase the costs of the Letter of Access. To comply with the REACH regulation and avoid hanging your activity, start your REACH 2018 registration as early as possible.
