Summary of Obligations | Avery Dennison | LPM

Summary of Obligations

Manufacturers and importers of substances in quantities of less than 1 tonne per year

  • Classify and label substances and mixtures that are placed on the market.
  • Notify classification of dangerous substances to the Agency for the classification and labelling inventory for all substances placed on the market.
  • Prepare and supply SDS sheets for substances and mixtures as required by Article. 31 and Annex II to downstream users and distributors. Prepare and supply information on non-classified substances as required by Article 32 to direct customers.
  • Conduct risk assessments and reduce risks for any chemical agent occurring at the workplace (Directive 98/24/EC on chemical agents at work).
  • Comply with any restrictions on manufacture, placing on the market and use of substances and mixtures as set out in Annex XVII.
  • Apply or decide not to apply for authorisation for use(s) of substances listed in Annex XIV.
  • In the case of having relevant data act as data holder in Substance Information Exchange Fora (SIEF).

Manufacturers of substances in quantities of 1 tonne or more per year

  • If you wish to secure the phase-in status of your substance, pre-register it to the Agency.
  • In case your substance is a non phase-in substance send an inquiry to the Agency whether the registration has already been submitted for the same substance.
  • Collect and share existing, and generate and propose to generate new, information on properties and use conditions of substances.
  • Prepare a technical dossier (note that special provisions apply for isolated intermediates).
  • Prepare CSA and CSR (for each chemical ≥ 10 tonnes/y per manufacturer).
  • Prepare CSA and CSR including exposure scenarios and risk characterization (for each chemical ≥ 10 tonnes per year per manufacturer, which are dangerous or fulfill the criteria as a PBT or vPvB).
  • Implement appropriate RMMs for own manufacture and use.
  • Submit registration for substances (≥ 1 tonne/y per manufacturer).
  • Keep the information submitted in the registration up-to-date and submit updates to the Agency.
  • Classify and label substances and mixtures that are placed on the market.
  • Notify/register classification of dangerous substances with the Agency for the C&L inventory for all substances placed on the market.
  • Prepare and supply safety data sheets for substances and mixtures as required by Article 31 and Annex II to downstream users and distributors.
  • Recommend appropriate RMMs in SDS.
  • Communicate ESs developed in CSA as Annex to the SDS (≥ 10 tonnes per year per manufacturer).
  • Prepare and supply information on non-classified substances as required by Article 32 to downstream users and distributors.
  • Conduct risk assessments and reduce risks for any chemical agent occurring at the workplace (Directive 98/24/EC on chemical agents at work).
  • Respond to any decision requiring further information as a result of the evaluation process.
  • Comply with any restrictions on manufacture, placing on the market and use of substances and mixtures as set out in Annex XVII.
  • Apply for authorization for use(s) of substances listed in Annex XIV.

Importers of substances and mixtures in quantities of 1 tonne or more per year

  • If you wish to secure the phase-in status of your substance, pre-register it to the Agency.
  • In case your substance is a non phase-in substance send an inquiry to the Agency whether the registration has already been submitted for the same substance.
  • Collect and share existing, and generate and propose to generate new, information on properties and use conditions of substances.
  • Prepare a technical dossier (note that special provisions apply for isolated intermediates).
  • Prepare CSA and CSR including exposure scenarios and risk characterisation (for each chemical ≥ 10 tonnes per year per manufacturer, which are dangerous or fulfil the criteria as a PBT or vPvB).
  • Implement appropriate RMMs for own use.
  • Submit registration for substances, on their own or in mixtures (≥ 1 tonne/y per importer).
  • Keep the information submitted in the registration up-to-date and submit updates to the Agency.
  • Classify and label substances and mixtures that are placed on the market.
  • Notify/register classification of dangerous substances with the Agency for the C&L inventory for all substances placed on the market.
  • Prepare and supply safety data sheets for substances and mixtures as required by Article 31 and Annex II to downstream users and distributors.
  • Recommend appropriate RMMs in SDS.
  • Communicate ESs developed in CSA as Annex to SDS (≥ 10 tonnes/y per importer).
  • Prepare and supply information on non classified substances as required by Article 32 to downstream users and distributors.
  • Respond to any decision requiring further information as a result of the evaluation process.
  • Comply with any restrictions on manufacture, placing on the market and use of substances and mixtures as set out in Annex XVII.
  • Apply for authorization for use(s) of substances listed in Annex XIV.

Producers of articles

  • Under some circumstances register substances in articles (tonnage trigger > 1 tonne/y per producer).
  • Comply with C&L, pre-registration and inquiry obligations if relevant.
  • Keep the information submitted in the registration up-to-date.
  • Under some circumstances notify substances in articles (tonnage trigger > 1 tonne/y per producer). When receiving SDS with ESs annexed for dangerous substances and mixtures to be incorporated into the articles:
    • If the use is covered by the ES, implement RMMs as set out in ES, or
    • If the use is not covered by the SDS annex, inform supplier of the use (i.e. make use known with the aim to make it an identified use) and await new SDS with updated ES(s) or conduct own chemical safety assessment and (if DU tonnage ≥ 1 tonne/y) notify the Agency.
  • Implement those RMMs as set out in SDS for dangerous substances and mixtures which are applicable when incorporated into the articles.
  • Conduct risk assessments and reduce risks for any chemical agent occurring at the workplace (Directive 98/24/EC on chemical agents at work).
  • Respond to any decision requiring further information as a result of the evaluation process (only relevant for registered substances).
  • Comply with any restrictions on manufacture, placing on the market and use of substances and mixtures as set out in Annex XVII.
  • Use substances authorized for incorporation into the articles as set out in the authorization or apply for authorization for use(s) of substances listed in Annex XIV.

Importers of articles

  • Under some circumstances register substances in articles (tonnage trigger > 1 tonne/y per producer).
  • Comply with C&L, pre-registration and inquiry obligations if relevant.
  • Keep the information submitted in the registration up-to-date.
  • Under some circumstances notify substances in articles (tonnage trigger > 1 tonne/y per importer).
  • Respond to any decision requiring further information as a result of the evaluation process (only relevant for registered substances).
  • Comply with any restrictions on manufacture, placing on the market and use of substances and mixtures as set out in Annex XVII.
  • Apply for authorization for use(s) of substances listed in Annex XIV.

Downstream Users

  • Check if the substance is placed on the list of pre-registered substances published by the Agency. If not, and considered relevant, ask the Agency to add the substance to the list.
  • In the case of having relevant data act as data holder in Substance Information Exchange Fora (SIEF).
  • Implement RMMs as set out in SDS.
  • When receiving SDS with ESs annexed:
    • If DU use is covered by the ES, implement RMMs as set out in ES annexes to SDS; or
    • If DU use is not covered by the SDS annex, inform supplier of the use (i.e. make use known with the aim to make it an identified use) and await new SDS with updated ES(s) or conduct own chemical safety assessment and (if DU tonnage ≥ 1 tonne/y) notify the Agency.
  • Prepare and supply SDS(s) and recommend appropriate RMMs in them and annex ES(s) for further downstream use.
  • Prepare and supply information on non-classified substances as required by Article 32 to further downstream users and distributors.
  • Pass on new information directly to their suppliers on the hazard of the substance and information that might call into question the RMM identified in the SDS for identified uses.
  • Conduct risk assessments and reduce risks for any chemical agent occurring at the workplace (Directive 98/24/EC on chemical agents at work).
  • Respond to any decision requiring further information as a result of the evaluation of testing proposals in downstream user reports.
  • Comply with any restrictions on manufacture, placing on the market and use of substances and mixtures as set out in Annex XVII.
  • Use authorized substances as set out in the authorization (this info should be found in the suppliers' SDS) or apply for authorization for use(s) of substances listed in Annex XIV.
  • Notify about using an authorized substance to the Agency.