Term and legal background of EINECS
The European Inventory of Existing Commercial Chemical Substances (EINECS) is a central chemicals registry within the European Union, playing a significant role in European chemicals law. EINECS serves as the official list of all chemical substances that were legally placed on the market in the EU or its then Member States between January 1, 1971, and September 18, 1981. Inclusion in EINECS has far-reaching legal consequences for manufacturers, importers, and distributors of chemical substances with respect to authorization, notification, and marketing eligibility.
Definition and purpose of EINECS
EINECS catalogs chemical substances that were already present on the European market prior to the introduction of EC chemicals legislation. The aim was to create a clear distinction between “existing” and “new” chemical substances within the EU’s legal framework and thus enable differentiated application of regulatory procedures. The substances listed are assigned a unique EINECS number, ensuring precise identification.
Legal foundations of EINECS
History and statutory basis
The legal basis for EINECS is found in particular in Directive 67/548/EEC (Substances Directive) and was later incorporated into Regulation (EC) No. 1907/2006 (REACH Regulation). The creation and publication of EINECS took place by the European Commission in 1990. The list served as a starting point for further legal regulations, particularly for the notification, registration, and evaluation of chemical substances.
Chemicals legislation prior to REACH
Prior to the entry into force of the REACH Regulation, there was a notification obligation for “new substances”, whereas “existing substances” (listed in EINECS) were exempt from this obligation. Specific transitional arrangements and notification duties applied to EINECS substances in the event of new scientific findings or changes in use.
Structure and significance of the EINECS number
Each substance listed in EINECS is given a unique EINECS number, consisting of seven digits (format: XXX-XXX-X). This number serves as a binding identifier in both intra-EU and international trade and is, for example, to be used on safety data sheets as well as in the application for authorizations.
EINECS and the REACH Regulation
Upon the entry into force of the REACH Regulation, the EINECS inventory was adopted as a legally binding reference tool for classifying substances as “existing” (phase-in substances) and “new” (non-phase-in substances). EINECS substances had to be registered by the manufacturer or importer before a certain transitional deadline (the so-called pre-registration) in order to be lawfully marketed in the European Economic Area.
Phase-in substances according to REACH
“Phase-in substances” include substances that are either listed in EINECS, produced or imported in the EU, or listed in special exemption lists. These substances benefit from staggered transitional periods and eased requirements for REACH registration, provided certain conditions were met.
Obligations and consequences of EINECS listing
Marketability and authorization
Manufacturers, importers, and distributors of EINECS substances are subject to specific legal obligations. EINECS listing alone does not confer marketability; however, it grants relief in certain notification, declaration, and registration obligations. Nonetheless, these substances remain subject to all further requirements under REACH, particularly regarding safety data sheets, hazard communication, and risk management.
Subsequent changes and updates
The EINECS inventory is closed and will no longer be supplemented or changed. New substances placed on the market after 1981 are registered in the European List of Notified Chemical Substances (ELINCS). Retroactive entry into EINECS is no longer possible; thus, careful verification of listing is essential for compliance with chemicals legislation.
Relationship to other substance registries
EINECS stands alongside other European substance registries such as ELINCS (European List of Notified Chemical Substances) and NLP (No-Longer Polymers List). This distinction is essential, as different substance regulations as well as registration and approval requirements apply.
Significance of EINECS for businesses and legal practitioners
EINECS assists companies and authorities in determining whether further notification requirements, registrations, or authorizations are necessary for a given substance under European chemicals law. Verification of the EINECS number is crucial for compliance, marketability, and product safety.
Sanction risks for non-compliance
Incorrect classification or failure to comply with registration obligations can have serious legal consequences. These include fines, sales restrictions, and recalls by supervisory authorities. Careful assessment of a substance’s EINECS status is therefore of high importance from a liability perspective.
Summary
The European Inventory of Existing Commercial Chemical Substances (EINECS) is a historically and legally central register in European chemicals law. The EINECS number serves as a prerequisite and proof for specific notification and registration requirements as well as for the marketability of chemical substances in the European market. Considering the EINECS status is a significant element of corporate and official legal practice within European Union chemicals law.
Frequently Asked Questions
What legal obligations arise for companies from the EINECS listing of a substance?
Listing a substance in the European Inventory of Existing Commercial Chemical Substances (EINECS) means that it was commercially traded in the EU or the former EEA before September 18, 1981. Legally, this has several consequences: In principle, all substances included in EINECS are categorized as “existing substances,” for which, until the entry into force of the REACH Regulation (EC No. 1907/2006), other – often easier – notification and registration requirements applied than for so-called “new substances” (notified in the “ELINCS” registry). Since REACH, however, EINECS-registered substances are also subject to the same requirements as other chemical substances: They must be notified (“registered”) if preconditions (e.g., quantity >1 tonne/year per manufacturer/importer) are met. Companies must demonstrate that their chemical substances can be used safely, provide substance data, and carry out exposure and risk assessments – otherwise, they face fines, recall measures, or distribution bans. Placing unregistered or incorrectly listed substances on the market violates REACH and can carry significant legal consequences.
Can an EINECS number legally serve as proof of marketability of a substance?
Entry of a substance with an EINECS number only demonstrates that the substance was commercially used or distributed in the common market before the 1981 cutoff date. However, it is not independent proof of marketability under current law. Legally, today’s requirements, especially the REACH Regulation and, where applicable, the Chemicals Act (ChemG) and other specific regulations, must be considered separately. Marketability is determined by the registration, authorization, and, if applicable, restriction of a substance in each individual case. This means: mere listing in EINECS confers no privileged status, but simply documents a particular legal status as of a certain date.
What obligations apply when handling EINECS substances under the REACH Regulation?
Fundamental requirements under REACH also apply to EINECS substances: Manufacturers and importers must register substances, provide safety data sheets (SDS) for them, and demonstrate appropriate risk management measures. There are also information obligations along the supply chain: Companies must ensure that relevant information on hazards and safe uses is passed on within the supply chain and that requirements for any existing authorization or restriction obligations are met. For EINECS substances subject to authorization requirements (Annex XIV of REACH), an application for authorization must also be made; otherwise, they may not be placed on the market or used.
Must a change in substance identity (e.g., new production process) for an EINECS substance be reported?
The legal status of an EINECS substance is linked to its specific identity as entered in EINECS. Changes in the method of manufacture, specification, or starting material that lead to a change in chemical identity may result, under the REACH Regulation, in it being classified as a “new substance” requiring separate registration. The legal responsibility lies with the respective company, which is obliged to check this and, if necessary, register the new variant accordingly. Failing to report such changes can result in violations of chemicals law and sanctions.
How must stocks of EINECS substances be handled from a legal perspective if they are still present after REACH entered into force?
For stocks that are still present after REACH entered into force (June 1, 2007), the following applies: These may be resold or used without REACH registration only if the substance was either already duly registered or falls under specific transitional provisions – for example, if they were produced or imported before the deadline and were therefore preregistered. Otherwise, the handling of stocks is also subject to all legal requirements from REACH and national regulations. Dealing with them without appropriate registration and documentation constitutes an administrative offense.
What legal consequences threaten in case of violations of requirements related to EINECS substances?
Companies that violate obligations regarding EINECS substances – for example, regarding notification, registration, or information duties under REACH – are subject to a range of sanctions: In addition to severe fines, these may include criminal liability, sales restrictions, withdrawal from the market, as well as claims for damages. Monitoring and enforcement are carried out by national chemicals and market surveillance authorities. Legal responsibility fundamentally lies with the distributor in question, regardless of whether they are a manufacturer, importer, or distributor.
Is it still mandatory to indicate the EINECS number, and if so, where?
In the legal context, it remains necessary to provide the EINECS number in certain cases, particularly in the safety data sheet (SDS) under Section 3 (“Composition/information on ingredients”) as well as in documentation submitted to authorities. It serves the unambiguous identification of a substance and is therefore an important tool for legally compliant communication within the supply chain. Missing or incorrect information can lead to objections during chemicals inspections. It is the company’s duty to ensure that the information provided is correct, current, and complete.
