SCIP Acronyms and Definition of Terms
Article - According to REACH Article 3(3), an article is an object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition. Articles that are assembled or joined together in complex objects remain articles, as long as they keep a special shape, surface or design, or as long as they do not become waste.
Complex Object - A “complex object” is an object made up of more than one article.
ECHA - The European Chemicals Agency (ECHA) is an agency of the European Union which manages the technical and administrative aspects of the implementation of the European Union regulation called Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). ECHA has no enforcement responsibilities, since it is a Community-level institution.
i6z Format - In IUCLID 6, the exchange of chemical information, from either datasets or dossiers, is facilitated via a zip/archive file that has the extension i6z, which stands for IUCLID 6 zip. The zip file contains a manifest file and the association documents/attachments.
IUCLID 6 - IUCLID (International Uniform Chemical Information Database) is a software application to record, store, maintain and exchange data on intrinsic and hazard properties of chemical substances. It is a key software application for both regulatory bodies and the chemical industry where it is used in the implementation of various regulatory programs. IUCLID implements the OECD Harmonized Templates and, since its version 6, is built as a platform meant to provide regulatory authorities and industry with a set of tools to manage information on chemicals, using a common format, facilitating the reuse and exchange of the data.
SCIP - Substances of Concern In articles as such or in complex objects (Products). Database for information established under the Waste Framework Directive (WFD). Companies that produce, import or supply articles containing Candidate List substances have to submit information on these articles placed on the EU market to the SCIP database, as of 5 January 2021.
Product - See Complex Object. In addition, the concept of “product” is usually understood as a term referring to anything “placed on the market”, whether in exchange for money or something else, or free of charge. As such, the term “product” encompasses substances, mixtures and articles under REACH. Therefore, the term “product” is intentionally not used within the context of the SCIP database.
REACH - Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). REACH is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals. It became effective 1 June 2007.
Registration Dossier - The registrant of a substance needs to compile all the required information in a registration dossier, which consists of two main components:
A technical dossier, always required for all substances subject to the registration obligations
A chemical safety report, required if the registrant manufactures or imports a substance in quantities of ten tonnes or more per year.
The registration dossier has to be prepared using the IUCLID6 software application. IUCLID6 implements the Harmonised Templates developed by the OECD and it is compatible with other chemical legislations around the world. Once the dossier has been created with IUCLID 5, it has to be submitted to ECHA through REACH-IT.
SCIP database - This database of information was established under the Waste Framework Directive (WFD) and has three main objectives:
Decrease the generation of waste containing hazardous substances by supporting the substitution of substances of concern in articles placed on the EU market.
Make information available to further improve waste treatment operations.
Allow authorities to monitor the use of substances of concern in articles and initiate appropriate actions over the whole lifecycle of articles, including at their waste stage.
Companies supplying articles containing substances of very high concern (SVHCs) on the Candidate List in a concentration above 0.1% weight by weight (w/w) on the EU market have to submit information on these articles to ECHA, as of 5 January 2021. The SCIP database ensures that the information on articles containing Candidate List substances is available throughout the whole lifecycle of products and materials, including at the waste stage. The information in the database is then made available to waste operators and consumers.
SVHC - A Substance of Very High Concern (SVHC) is a substance that meets one or more of the criteria defined in Article 57 of the EU REACH Regulation and is put on the "candidate List for authorization" (typically referred to as the REACH SVHC list). Substances on the REACH SVHC list are:
substances meeting the criteria for classification as carcinogenic, mutagenic or reprotoxic (CMR) category 1 or 2;
persistent, bioaccumulative and toxic (PBT) substances; or
very persistent and very bioaccumulative (vPvB) substances;
substances for which there is evidence for similar concern, such as endocrine disruptors.
SVHC Candidate List - Once a substance is identified as an SVHC, it is included in the Candidate List. The inclusion in the Candidate List brings immediate obligations for suppliers of the substance, such as:
supplying a safety data sheet
communicating on safe use
responding to consumer requests within 45 days and
notifying ECHA if the article they produce contains an SVHC in quantities above one tonne per producer/importer per year and if the substance is present in those articles above a concentration of 0.1% (w/w).
Technical Dossier - Manufacturers and importers have to collect all existing available information on the intrinsic properties of a substance as well as on its manufacture, uses and exposure.
The technical dossier contains information about:
The identity of the substance
Information on the manufacture and use of the substance
The classification and labelling of the substance
Guidance on its safe use
(Robust) study summaries of the information on the intrinsic properties
Proposals for further testing, if relevant
For substances registered in quantities between one and ten tonnes, the technical dossier also contains exposure related information for the substance (main use categories, type of uses, significant routes of exposure)
WFD - Waste Framework Directive (WFD). The Waste Framework Directive sets out measures addressing the adverse impacts of the generation and management of waste on the environment and human health, and for improving efficient use of resources which are crucial for the transition to a circular economy.The revised Waste Framework Directive entered into force in July 2018. It gave ECHA the task to develop a database with information on articles containing substances of very high concern (SVHCs) on the Candidate List.