Guidance "Development and update of a technical dossier for the registration of chemicals by a non-EU manufacturer in accordance with the requirements of the REACH Regulation in IUCLID 6 software"

Starting from 21 June 2016, the European Chemicals Agency accepts applications for the registration of chemicals that are only created in IUCLID 6 software or directly in REACH-IT.

IUCLID has undergone a number of major changes as a result of ECHA's ongoing work to improve the enforcement of the REACH Regulation.

The guidance provides a clear explanation of how to work in IUCLID 6, the correct completion of technical dossier fields to develop a valid dossier that will pass checks in REACH-IT.

news

Guidance“Rules and procedures for conducting inspections of Ukrainian chemical enterprises by national competent authorities. Rights and responsibilities of competent authorities and economic operators. Prerequisites for successful passing the inspection. »

This guidance is designed for chemical companies, legal entities registered in Ukraine, which manufacture or sale various chemical products.

Guidance highlights the procedures for state supervision of chemical companies and products placed on the market or manufactured in order to ensure safety of human health and the environment, as well as to prevent emergencies. The guidance does not consider the prerequisites and procedures for state supervision of financial operations of companies, formal organization of their activities, etc. Read in full

news

Guidance "European criteria for the prioritization of substances of very high concern (SVHC) for inclusion in Annex XIV (List of substances subject to authorization)".

This workshop examines the criteria for prioritizing substances of very high concern (SVHCs) for their withdrawal from the EU market with the transitional option of obtaining a temporary authorization for use - inclusion in Annex XIV of the EU REACH Regulation.

Substances with certain hazardous properties that cause special harm to human health or the environment, according to new world trends (including European) are considered separately, studied in depth, and often such substances are restricted or banned for some or for all uses. Read in full

news

Guidance "Hazardous chemicals, mixtures and products containing them. Existing and forecast restrictions on use by countries. Practical recommendations for national exporters »

Substances with certain hazardous properties that cause special harm to human health or the environment are considered separately, studied in more depth in accordance with new world trends, and such substances are often restricted or banned for some or all uses. As a result of systematic research, such substances can be detected among previously relatively safe substances, and later - regulated. The purpose of such regulation and imposition of restrictions is to properly control the risks associated with the use of these substances. Read in full

news

Guidance on the development of a safety data sheet for a substance or mixture in accordance with Regulation №1907/2006 (REACH) and DSTU GOST 30333:2009.

This guidance is based on the requirements of the Safety Data Sheet (SDS, eSDS) set out in the following official documents:

  • Annexes I and II of the REACH Regulation ("General provisions for substance evaluation and development of chemical safety report", "Guidance on the development of a safety data sheet");
  • Regulation EU № 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP Regulation);
  • Guidance on information requirements and chemical safety assessment. Part G: Advanced SDS;
  • DSTU GOST 30333: 2009 "Safety data sheet of chemical product" (entered into force on 01.01.2010);
  • DSTU GOST 30340: 2009 "Precautionary labeling of chemical products".

This guidance includes all the new requirements and clarifications for the development of a safety data sheet set out in the new ECHA Guidance.

In the process of developing this guidance, other international regulations governing the production, use, storage, transportation, disposal, destruction of substances and mixtures were used.

news

Guidance on search and use of source data (scientific and technical, technological, toxicological, ecotoxicological, etc.) information for the development of registration dossiers, safety data sheets SDS / eSDS and other documents for substance evaluation (mixture). Analysis of informativeness, reliability and accessibility of world and national databases.

In this guidance shows approaches to finding and using information on chemical safety for the development of SDS, registration dossiers and chemical safety assessment in accordance with the EU REACH Regulation and GHS.

The paper provides links to all current databases on chemicals as of 2016.

news

Guidance “Substances in articles under REACH”

Guidance presents the requirements of the EU REACH Regulation, which are set for articles and chemicals in their composition.

Issues related to the registration of substances in articles, notifications to the ECHA on substances in articles, the transfer of information along the supply chain, restrictions on the use of substances in articles are discussed in detail in this paper.

news

Guidance on authorization for especially hazardous substances exported to the EU.

Some of chemicals of high concern that pose a particular threat and cause uncontrolled risks (SVHCs) will be permanently removed from the EU. Such substances are included in Annex XIV of the EU REACH Regulation and in order to ensure a smooth transition of the industry to alternative substances, the Regulation envisages to obtain a temporary permit (authorization) for their specific use, after which they will be withdrawn from the market.

This guidance details the authorization procedure for substances under the EU REACH Regulation and provides practical guidance for successful compliance.

news

Guidance on identification of substances of very high concern (SVHC). Criteria for assigning to hazardous chemicals the status of SVHC and their inclusion in the list of candidate substances for the authorization procedure.

Guidance presents the features of the regulation of hazardous chemicals in the EU, which pose a special threat and posess uncontrolled risks - the so-called SVHC-substances (literally - of very high concern).

According to the EU REACH Regulation, such substances are identified, inventoried, tracked and considered for further regulatory measures, such as restrictions on use or permanent withdrawal from the market.

Guidance specifies the criteria for identifying substances as SVHC and the procedures for their inclusion in the Candidate List.

news