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.

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.

The target users of the guidance does not include manufacturers of pharmaceutical and veterinary products, food, feed, nuclear materials, military products, although many of the described procedures of state supervision may affect such companies, because in their activities sphere they use chemicals, including hazardous, emit such substances or their derivatives into the environment and put at risk their employees for adverse exposure.

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.

Due to the fact that in-depth studies of hazardous properties are systematically conducted, such substances can be detected among previously relatively safe substances, and later - regulated. The purpose of such regulations and restrictions is to properly control the risks associated with the use of such substances, as well as the complete withdrawal of such substances from the EU market with transitional periods, but the use of transitional provisions of such bans authorization is required (temporary authorization for use).

According to Article 57 of REACH and the relevant annexes to the Regulation, the criteria for identification a substance as of high concern - SVHC are established.

A substance of very high concern (SVHC) – literally translated as a substance that cause special concern. Substances identified as SVHC are included in the Candidate list. Further, in addition to registration, they may be subject to an authorization procedure for certain uses, once the SVHC substance has been included in Annex XIV of the REACH Regulation.

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.

One way or another, the criteria for classifying a chemical as especially hazardous and prioritizing it are based on the current hazard classification scheme in a particular country. Methods and ways of including a substance in the lists of especially hazardous vary from country to country, depending on the requirements of relevant regulations, but they are similar and aimed at identifying carcinogenic, mutagenic and highly toxic properties of the substance and the ability of the substance to accumulate in environmental and biological systems. The most developed and modern approach to the identification of a substance as especially hazardous (of very high concern) is presented in the EC Regulation 901907/2006, and it is mostly repeated in similar regulations in other countries.

Guidance presents all the important definitions, deciphered abbreviations to facilitate understanding of processes and reading of "chemical" EU legislation.

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.

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.

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.

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.

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.