Q&A info

REACH imposes registration obligations only on manufacturers or importers (and, in specific cases, on producers or importers of articles). The registration obligation does not apply to downstream users or distributors. Therefore, the registration obligation does not apply to you if you have:

• manufactured or imported pre-registered substances before the registration deadline; and
• completely ceased such activities and only used the substances and/or supplied them after that.

For example, importers for whom the last batch of the substance was imported on 31 May 2018, at the latest, may continue to use and/or supply that substance after the deadline without a registration, without time-limitation. Since the pre-registered substance has not been registered, there is no obligation to notify ECHA of the cessation of manufacture/import. Article 50(2) and (3) of the REACH Regulation does not apply to this situation.

If you have not ceased your activities before the registration deadline, you have an obligation to register the substance according to Article 6 of REACH.

If you are a downstream user (or any other actor down the supply chain) who is not subject to the registration obligation, you can continue to use, without time-limitation, and/or supply quantities of the substance that were manufactured or imported before the registration deadline.

For the obligations of a downstream user or distributor and whether they are obliged to check the registration status of the substances on their own or in a mixture, please see Q&A 155

Substances that fulfil at least one of the following criteria may be considered as phase-in substances in accordance with Article 3(20) of the REACH Regulation:

• Substances listed in the European Inventory of Existing Commercial chemical Substances (EINECS);
• Substances that have been manufactured in the EU (including accession countries on 1 January 2007) but have not been placed on the EU market after 1 June 1992;
• Substances that qualify as a so-called ‘no-longer polymer’.

Detailed information can be found in the Guidance on registration, Section 2.3.1. – Phase-in substances vs non phase-in substances.

• Substance EINECS and CAS number (if available) and other identity codes;
• The first envisaged registration deadline;
• The names and other identifiers of related substances that pre-registrants have, i.e. those for which the available information may be relevant for performing adaptation of testing requirements using read across, (Q)SARs and/or grouping of substances.

Ainda que um pré-FIIS possa ter muitos participantes, é possível que muitos deles estejam indecisos quanto ao registo ou tenham decidido não o efetuar. O estatuto «inativo» no pré-FIIS indica que a empresa não efetuará o registo, mas nem todas as empresas o utilizam.

Se as empresas não responderem às suas mensagens de correio eletrónico, poderá tentar contactá-las por outra via (caso o endereço de correio eletrónico esteja desatualizado). Poderá restringir-se às empresas que conhece ou que são mais suscetíveis de efetuar o registo.

Será igualmente útil descarregar, regularmente, o ficheiro pdf dos pré-registantes para conferir se os dados de contacto foram alterados. Tenha em atenção que as comunicações podem ser consideradas «spam» e eliminadas.

Se as novas tentativas de estabelecer contacto se revelarem infrutíferas, documente as tentativas realizadas e prepare-se para efetuar o registo individual da sua substância. Mantenha os outros participantes do pré-FIIS informados, por correio eletrónico, a respeito dos progressos realizados. Pondere tornar-se o Facilitador da Formação do FIIS (FFF), indicando no pré-FIIS a forma de os outros participantes o contactarem.

Se a sua substância for complexa, considere a possibilidade de que outros fabricantes/importadores da substância não terem utilizado o mesmo identificador e se encontrem, por isso, num pré-FIIS diferente. Pesquise, na lista de substâncias pré-registadas, pré-FIIS para uma possível fusão.

The pre-registrations are not valid as of 1 January 2020 following the Commission Implementing Regulation (EU) 2019/1692.

Companies must register substances that they manufacture or import in quantities of more than one tonne per year in the EU/EEA before they start these activities, unless the substances are exempt from registration.