Registratie
Registration is when you submit documentation to ECHA which shows that the substance you deal with is handled safely throughout the supply chain, ensuring that human health and the environment are protected.
The documentation you need to submit depends on the volume of the substance you put on the market, the hazards of the substance, and whether or not the substance is only used as an intermediate in the manufacture of another substance under strictly controlled conditions.
The documentation needs to be provided in a registration dossier. The registration dossier includes a description of the uses of the substance, the physico-chemical, ecotoxicological and toxicological properties, and a hazard and risk assessment showing how the risks posed by the use of the substance are controlled.
Registrations are submitted in a IUCLID format through a tool called REACH-IT. In most cases, you need to pay a registration fee.
Each substance needs its own registration. If you deal with mixtures of substances, such as detergents and paints, or articles releasing substances, you need to register the different substances that are in the mixture or article.
You also need to identify and name your substances according to the same rules and criteria, so you can see if your substances are the same as in other companies. If this is the case, you need to register together.
For your registration, you need to collect information on your substance and share it with the other companies registering the same substance. This applies in particular to ecotoxicological and toxicological information. By sharing data you can avoid unnecessary testing on animals and reduce costs.
You will need to agree on the information to be submitted for a substance and register it jointly, although not necessarily at the same time. ECHA's data-sharing processes (pre-registration and inquiry) will help you to get in contact with other registrants, and must be followed before you register.
Now, you need to register any substance before you manufacture or import it into the European Economic Area.
Before 31 May 2018, the type of your substance (phase-in or non-phase-in) determined the timing of your registration. For any dossiers submitted after 31 May 2018, you need to wait until you receive your registration number before starting manufacture or import of your substance.
The transitional regime for registering pre-registered phase-in substances under REACH ended on 31 May 2018.
To clarify how certain REACH provisions apply after that date, the European Commission issued the Implementing Regulation (EU) 2019/1692 of 9 October on the application of certain registration and data-sharing provisions of REACH after the expiry of the final registration deadline for phase-in substances.
The main points companies need to pay attention to are:
Calculating annual volumes
If a company has pre-registered a substance but has not registered it yet, and they have manufactured or imported the substance during the preceding three years, they have to calculate their annual volume as an average of those three years, and register before the annual volume reaches 1 tonne per year. This applies until 31 December 2019.
After that date, the annual volume is determined per calendar year for all substances.
If a company has registered their substance, the annual volume is calculated per calendar year. This is relevant, for example, if the company needs to update their registration to a higher tonnage band.
Reduced information requirements
Phase-in substances that do not fulfil any of the criteria set in Annex III of REACH can still be registered with reduced information requirements, i.e. submitting only physico-chemical information of Annex VII, if registration is done in the lowest tonnage band (1-10 tonnes/year).
For phase-in substances that fulfil at least one criterion of Annex III, as well as for non-phase-in substances, a full Annex VII data set including toxicological and ecotoxicological information needs to be provided.
Data sharing
If a company has pre-registered a phase-in substance, they do not have to submit an inquiry for that substance if they submit their registration by 31 December 2019. If a company wants to register any substance after that, they will first have to submit an inquiry to ECHA to be put into contact with the previous registrants of the substance.
If data-sharing negotiations started within a substance information exchange forum (SIEF), respective data-sharing dispute can be submitted according to Article 30(3) of REACH until 31 December 2019. After this date, all data-sharing disputes will be handled according to Article 27.
Joint submission and data sharing obligations of companies continue, and co-registrants are encouraged to maintain informal communication platforms for these purposes. Registrants must keep their registrations up-to-date reflecting new information on their substances.
The transitional system for registering phase-in substances ended on 31 May 2018. The Implementing Regulation (EU) 2019/1692 has clarified how substances should be registered after this date.
As of 1 January 2020, you must determine your obligation to register based on the volume of the substance you manufacture or import per calendar year. Calculation based on the three-year average for phase-in substances no longer applies.
For further information, see the section ‘Your registration obligations’.
As of 1 January 2020, you can no longer use your pre-registration as a starting point for registering your substance. Instead, before registering, you need to submit an inquiry to ECHA.
As of 1 January 2020, the duty to inquire will also apply to substances that you have pre-registered before, but not yet registered. If you are planning to register any substance, you must inquire with ECHA if a registration has already been submitted for that substance. You will then receive the contact details of the previous registrants, if any are present in the database, to support you with the data sharing and joint registration obligations.
For further information, see the section ‘Finding your co-registrants’.
Although formally the participants of Substance Information Exchange Forums (SIEFs) no longer have the obligation to respond to requests, the obligation to share data and register jointly continues to apply to all co-registrants of the same substance.
Co-registrants must still make every effort to share the data and make sure that the cost of sharing information is determined in a fair, transparent and non-discriminatory way.
The Implementing Regulation recommends that registrants use similar informal communication platforms as the ones they used for registering phase-in substances until 31 May 2018.
For further information, see the section ‘Working together’.
As of 1 January 2020, you can only submit data sharing disputes under Article 27. Submitting disputes under Article 30 will no longer be possible, even if the negotiations started before 31 May 2018. This means that claimants can receive permission to refer to all studies in the registration (Article 27), as opposed to only the vertebrate studies (Article 30).
For further information, see the section ‘Working together’ > ‘Disputes in practice’.
Phase-in substances that do not meet the criteria in Annex III of REACH can continue to benefit from reduced information requirements when you register them in the lowest tonnage band (1-10 tonnes per year).
If your substance fulfils the conditions to benefit from reduced information requirements, you can register it by submitting a registration dossier with information only on its physicochemical properties. Alternatively, you can submit your registration with the full information required for a 1-10 tonnes per year registration, and claim a fee waiver to have a reduction in your registration fee.
For further information, see the section ‘What information you need’ > ‘Reduced information requirements’. This option applies only to phase-in substances.
Since the transitional regime for phase-in substances ended, declaring the phase-in status in your registration is no longer needed in most cases.
You must however continue to declare the phase-in status of the substance in your registration in the following cases:
- If you register a phase-in substance not meeting the Annex III criteria in the lowest tonnage band (1-10 tonnes per year) with reduced information requirements;
- If you register a phase-in substance not meeting the Annex III criteria in the lowest tonnage band (1-10 tonnes per year), with the standard information requirements and you claim a fee waiver;
- If you make a confidentiality request for a period of 6 years on the name of your non-phase-in substance.
You must determine the phase-in status of your substance based on the definition of a phase-in substance. Whether or not you pre-registered the substance is not relevant.
A substance is defined as a phase-in substance if it meets at least one of the following criteria:
- It is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS). [Substances with EC number starting with 2 or 3 are listed on EINECS.]
- It was manufactured/ imported in a Member State, but not placed on the market by the manufacturer or importer, between 1 June 1992 and 31 May 2007, provided that you have documentary evidence of this.
- It was placed on the market in a Member State before 1 June 2007 by the manufacturer or importer and it qualifies as ‘no-longer polymer’ (NLP), provided that you have documentary evidence of this. [Substances with EC number starting with 5 are NLP.]
Otherwise your substance is a non-phase-in substance.
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Registratie
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