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PED Professional 6

Registration and deadlines

Requirements for registration


You need only submit registrations of the substances in your articles if the following conditions are fulfilled
  • The substance is present in those articles in quantities totalling over one tonne per year and per producer/importer.
  • The substance is intended for release under normal or reasonable foreseeable conditions of use. Examples include but are not limited to dyes/pigments in printer ink, artificial scents in scented candles or detergents released from cleaning cloths.
  • The ECHA is determining further risks.
Please take into account that the above conditions apply to substances in articles, but not to substances on their own or substances in mixtures.

REACH provides for registration deadlines depending on tonnage:
  • Substances from 1000t/a must have been registered since 1 December 2010
  • Substances over 100t/a must have been registered since 1 June 2013
  • Substances over 1 t/a had to be registered by 1 June 2018
CMRs (substances that are carcinogenic, mutagenic, and toxic for reproduction) from 1 t/a and substances classified as N (R50-53) in quantities over 100 t/a also had to be registered by 1 December 2010.

How to register substances


In contrast to pre-registration, the registration of substances is both complex and time-consuming. In addition, the observance of deadlines is imperative

1

Registration basically consists of the following key elements:

Following initial registration

The first hurdle has been taken and the first registration period under REACH has passed.

These tasks may now await you:
  • Registration may have to be updated, e.g. in case of new identified uses (see Art. 22 REACH).
  • Under Article 7 (2, 4) of REACH, importers of articles containing SVHC need to notify the ECHA of certain information. This applies from June 2011 onwards but on registration at the latest, and in cases where the SVHC is present in these articles in quantities totalling > 1 t/a and above a concentration of 0.1 %.
  • Manufacturers established outside the EU need an Only Representative (OR)* to fulfil the obligations under Art. 7 (2, 4), REACH, unless the notification to the ECHA is carried out by the importers.
  • The following already applies: in accordance with Article 32 (1) suppliers of articles containing SVHC in a concentration of > 0.1 % must provide the recipient of the article with information to allow safe use of the article.
  • A further already applicable provision is that in accordance with Art. 32 (2), suppliers need to provide this information to consumers on request.
  • In accordance with Articles 39 and 40 of the CLP regulation, manufacturers and importers of hazardous substances need to notify the classification and labelling inventory of the ECHA of these substances. This requirement applies irrespective of any quantity thresholds. The provision does not apply if the company has already fully registered the substance under REACH.
  • In accordance with the CLP regulation, hazardous substances and hazardous mixtures must be classified and relabelled:
    Deadline for substances: 1 December 2010
    Deadline for preparations: 1 June 2015 .
  • The CLP regulation may also require adjustment of the transport classification, in particular with respect to the hazard categories "environmental hazards", "corrosive/irritant to skin" and "corrosive to metals".
  • As a result of REACH and CLP, the manufacturing, storage and use of chemical substances and products may have to be reassessed from an organizational and technical perspective in individual cases (e.g. if the classification of a substance has changed) and, if necessary, aligned to the requirements (e.g. in terms of fire safety, occupational health and safety, air-pollution control, waste disposal etc.).
  • In accordance with Art. 31 REACH, safety data sheets must be aligned to Annex I of the REACH regulation and the requirements of the CLP regulation, If necessary, new safety data sheets may have to be drawn up.
  • Any actor in the supply chain who has prepared a chemical safety report under REACH must prepare "extended safety data sheets".
* Note:
Calling in an only representative (OR) has the following advantages: importers need not become active themselves, and manufacturers established outside the EU can bundle notifications and do not have to address each importer individually.


Performing an exposure assessment for dangerous substances, PBT substances or vPvB substances


If the registrant concludes within the scope of chemical safety assessment that the substance
  • fulfils the criteria for classification as dangerous, or
  • is a PBT substance, or
  • is a vPvB substance
the following steps must be carried out within the scope of chemical safety assessment:
  • Exposure assessment
  • Development of exposure scenarios
  • Risk characterization
This applies to any use of the substance identified by the registrant.

SIEF


Even if not explicitly referred to in the REACH regulation, SIEF participants may appoint a SIEF facilitator who carries out certain assignments (e.g. determination of substance identity, organizational tasks).

Communication in the SIEF may involve risks in terms of trade secrets and with respect to unintended violations of competition and cartel law.

Communicating certain information via an independent trustee would therefore be a sensible solution.

Frequently asked questions:
FAQ

Contact:

TÜV SÜD Industrie Service GmbH, München