Registration, Evaluation and Authorization of Chemicals (REACH)

Background

The European Union is the world's largest importer and exporter of chemicals, accounting for approximately half of global trade. Since 1967, the EU has been enacting a series of regulations related to chemicals, but the high degree of repetition and inefficiency led to the integration of over 40 existing regulations into a consolidated legislative document along with corresponding technical guidance documents. The REACH regulation, adopted in 2006, came into effect in 2007, and was fully implemented by 2008. Its purpose is to protect human health and the environment, maintain and enhance the competitiveness of the EU chemical industry, increase transparency and consumer awareness, promote non-animal testing, and fulfill the EU's international obligations under the WTO.

REACH stands for Registration, Evaluation, Authorization, and Restriction of Chemicals. As the name suggests, this directive requires chemical products entering the European market to undergo registration, evaluation, authorization, and restriction measures based on the import volume.

Effective Date: June 1, 2007

Regulatory Authority: European Chemicals Agency (ECHA), based in Helsinki, Finland

Industries Affected: Applicable to all chemicals, including those used in chemical processes, industrial applications, consumer products such as cleaning agents, paints, clothing, furniture, and electronics. Substances, mixtures, and articles are all subject to regulation.

Applicable regions

European Union countries

All countries of the European Union member states, including Finland, France, Germany, Greece, Sweden, Austria, Belgium, Czech Republic, Denmark, Hungary, Ireland, Italy, Netherlands, Poland, Portugal, Spain, Latvia, Estonia, Bulgaria, Croatia, Cyprus, Lithuania, Luxembourg, Malta, Romania, Slovakia, and Slovenia, must comply with this directive for products exported to these countries.

Non-European Union countries

Many countries outside the European Union have begun implementing the REACH regulation or adopting similar regulatory frameworks to establish a more globalized chemical registration system under the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). Balkan countries such as Croatia and Serbia are adopting the EU REACH system with support from the EU IPA project. Switzerland partially revised its Swiss Chemicals Ordinance on February 1, 2009, moving towards the implementation of REACH. Turkey's new chemical management regulations pave the way for the adoption of REACH, planned for 2013. China is moving towards a more efficient and consistent approach with a chemical control system compliant with the GHS.

In the UK, the government announced "UK REACH," which the UK Chemical Industries Association described as an "extremely costly duplication" of EU safety data. The new regulations were set to come into effect in October 2021 but were postponed to October 2023 and further delayed to October 2025. Following industry statements, the responsible minister announced that officials would explore a "new model" for UK REACH registration, seeking to "reduce the need for duplicating EU REACH packages." In March 2021, a coalition of over 20 leading UK organizations, including CHEM Trust and Breast Cancer UK, rejected industry proposals to simplify UK REACH, considering it a "significant weakening" of the post-Brexit regime.

Examples of Chemical Inventories from Various Countries

• Regulation (EC) No 1907/2006 (REACH) - European Union

• AICS – Australian Inventory of Chemical Substances

• DSL – Domestic Substances List (Canada)

• NDSL – Non-Domestic Substances List (Canada)

• KECL (Korean ECL) – Korean Existing Chemicals List

• ENCS (MITI) – Existing and New Chemical Substances (Japan)

• PICCS – Philippine Inventory of Chemicals and Chemical Substances

• TSCA – Toxic Substances Control Act (United States)

• Giftliste 1 (Swiss Inventory of Toxic Substances, abolished in 2005)

About REACH

(According to the criteria for imported products' compliance, determine which measure should be taken below. Not all measures need to be implemented):

• Registration: Importers and manufacturers importing goods into the European Union with an annual import volume of 1 tonne or more (including 1 tonne) must register with the European Chemicals Agency (ECHA). Registrants must be legal entities within the EU, and upon successful submission of a registration dossier for a chemical substance to ECHA, a registration number consisting of 18 digits will be issued. Enterprises that fail to complete registration by the corresponding deadline cannot continue placing the corresponding products on the EU market. Depending on whether the substance is listed in the existing EU chemical inventory, registration types can be categorized as "phase-in substance registration" and "new substance registration." Furthermore, exemptions from registration include certain medicinal products, polymers, existing natural substances such as oxygen and water, as well as naturally occurring minerals and ores (when not chemically treated). Exemptions under the REACH regulation also apply to radioactive substances, inseparable intermediates, waste, customs-controlled substances, and materials for defense purposes.

• Evaluation: Evaluation is undertaken by ECHA and is divided into two types: Dossier Evaluation and Substance Evaluation. "Dossier Evaluation" involves verifying the completeness and consistency of the dossiers submitted by companies, while "Substance Evaluation" aims to identify the risks posed by chemical substances to human health and the environment. ECHA ensures consistency in evaluation criteria, provides member states with substance screening assessment criteria, and assesses whether further requests for specified substance information are necessary. According to the REACH regulation, companies manufacturing or importing chemicals exceeding 10 tonnes/year are required to conduct a Chemical Safety Assessment (CSA) for their substances and prepare a Chemical Safety Report (CSR) as part of the registration dossier submission. Chemical safety assessment includes human health assessment, physicochemical assessment, environmental hazard assessment, PBT assessment, and vPvB assessment. If a substance assessed meets the classification criteria for hazardous substances under Directive 67/548/EEC or is identified as a PBT or vPvB substance, the chemical safety report for that substance should include exposure scenarios for all identified uses, exposure assessment, and risk characterization. These exposure scenarios should be included as annexes in the Safety Data Sheet (SDS).

• Authorization: The purpose of authorization is to "ensure the stable functioning of the internal market in the EU while ensuring that high-risk products are adequately controlled and ultimately replaced by other more suitable technologies or substances." Therefore, authorization is a mechanism that allows highly concerning substances that should be phased out of the market to continue being used conditionally through risk management procedures. If a substance imported into the EU is classified as a Substance of Very High Concern (SVHC) at concentrations exceeding 1000 ppm (>0.1% w/w), and the annual import volume of that substance exceeds 1 tonne, producers, importers, or downstream users in the supply chain need to notify and submit an authorization application for the use of the chemical substance to the European Chemicals Agency (ECHA). Enterprises must obtain authorization to continue using the substance after a specific deadline. These substances are called "authorized substances," and once identified as substances of very high concern, they are listed in Annex XIV of the authorization candidate list. This includes CMRs (carcinogenic, mutagenic, and toxic substances), PBTs (persistent, bioaccumulative, and toxic substances), and vPvBs (very persistent and very bioaccumulative chemicals). Within the REACH regulation, these are referred to as authorization substances listed in Annex XIV. https://echa.europa.eu/authorisation-list

• Restriction: This procedure strictly controls manufacturers and importers from placing on the market hazardous chemicals under conditions or prohibiting their use unless specific conditions in the restriction clauses are met, such as limits on concentration. For example, bans on asbestos or restrictions on certain azo dyes. Within the REACH regulation, these are referred to as hazardous substances listed in Annex XVII (as of September 2023, there are 73 entries).

https://echa.europa.eu/substances-restricted-under-reach

About SVHC

SVHC stands for Substance of Very High Concern, referring to substances that pose risks to human health and the environment. Products containing SVHCs require corresponding responsibilities and obligations. As the implementation of REACH progresses, the European Chemicals Agency (ECHA) continually publishes batches of SVHC lists. Approximately every six months, a new list is updated. As of January 2024, there are 240 substances listed.

Official List: https://www.echa.europa.eu/candidate-list-table

According to Article 57 of the REACH regulation, substances meeting one or more of the following hazardous properties are identified as Substances of Very High Concern (SVHC):

1. Substances classified as carcinogenic (Category 1A or 1B), mutagenic (Category 1A or 1B), or toxic for reproduction (Category 1A or 1B), commonly referred to as CMR substances.
2. Substances that are persistent, bioaccumulative, and toxic (PBT).
3. Substances that are very persistent and very bioaccumulative (vPvB).
4. Substances with endocrine-disrupting properties, persistence, bioaccumulation, and toxicity, or high persistence and high bioaccumulation but not falling under the second or third categories, and for which there is scientific evidence of serious effects on human health or the environment.

European Union Member State competent authorities or agencies can propose substances that meet the above criteria to be included in the SVHC Candidate List. Stakeholders will be invited to participate in a public consultation on the proposed substances, with a consultation period of 45 days. Once the discussion is concluded and the substance is approved, it becomes an SVHC substance, also known as a substance on the Candidate List for Authorization.

The ezGPM.NET platform will update in real-time according to the REACH SVHC regulations, allowing users to access the complete REACH regulatory content and stay informed about the latest regulatory changes.

REACH Annex XIV Authorized Substances

Appendix XIV lists SVHCs that pose a particularly high risk to human health or the environment (based on their intrinsic properties, quantities, and uses), prohibiting their use in the EU market.

The recommendation to include SVHCs in Annex XIV is proposed by ECHA and debated by all relevant stakeholders (member states, companies, non-governmental organizations, etc.). The final decision to include the substance in Annex XIV is made by the European Commission.

Therefore, when a substance is listed in Annex XIV of the REACH regulation, it is assigned a "sunset date," after which the use of the substance will be prohibited unless authorized within a certain period.

The REACH Annex XIV candidate list is typically updated every 12 to 18 months.

The scope of authorization

The authorization process under Annex XIV is complex, involving manufacturers, importers, downstream users, and the unique representative of the substance, applicable in the following scenarios:

When technically and/or economically feasible alternatives to Annex XIV substances do not exist. When alternatives may exist but still require time for full qualification and deployment. The prohibition of use will come into effect after the "sunset date." Until that date, the use of the substance is only applicable to companies that have been authorized or have submitted files before the latest application date.

Review Period

The review period is the duration during which the European Commission authorizes the continued use of a substance after the sunset date. The review period takes into account the following durations:

• < 7 years: When the alternative analysis report is insufficient and/or doubts remain about the impact of granting authorization, or when rapid transition is feasible.
• 7 years: The standard timeframe for the development of technically and economically feasible alternative solutions.
• 12 years and >12 years: Long investment cycles with low risk. In special circumstances, longer periods may be considered if it can be demonstrated that a 12-year or longer review period would have a disproportionate impact compared to shorter durations.

At the end of the review period, the authorization application will be reassessed to evaluate progress made in terms of conditions, research, or alternatives. Applications to extend the review period must be submitted no later than 18 months before the expiry of the validity period.

If new risks or impacts arise, the European Commission may also shorten this period.

Only the Court of Justice of the European Union is eligible to make rulings on appeals regarding authorization applications. Conversely, member states are responsible for controlling the implementation of that decision.

REACH Annex XVII Hazardous Substances

The difference between Annex XVII and SVHC

	Substance of Very High Concern(SVHC)	Annex 17 Dangerous Substance
Concentration calculation"	Calculated in terms of 'Articles' according to the definition of finished products by REACH-ECHA.	Most are calculated based on 'homogeneous materials', while a small portion is calculated based on finished products.
Limit	Each item fixed at 0.1% (w/w) =1000 ppm= 1000 mg/Kg	Each one has its own limit.
Type of substance	Monitoring substances	Restricted substances
Follow-up actions	Exceeding the limit requires providing safety usage information according to Article 33.	Exceeding the limit and prohibition of sale and manufacture.

Industry practices

REACH does not provide standardized declarations or certificates. Therefore, each manufacturer must determine their role under the REACH regulation and comply with the relevant requirements at different levels, including registration, evaluation, authorization, and restriction.

Regular Monitoring: The REACH SVHC substance list is updated biannually, around June and December each year. Relevant stakeholders should pay attention to these updates.

Supply Chain Communication: If the concentration of Substances of Very High Concern (SVHCs) in articles exceeds 0.1% (w/w), and the annual import volume of the substance exceeds one ton, EU manufacturers or importers must notify the European Chemicals Agency (ECHA). Manufacturers and importers must communicate supply chain information, providing customers and suppliers with sufficient safety information regarding SVHCs. If consumers request safety information, product suppliers must provide it free of charge within 45 days. Companies must bear the responsibility of "chemical safety information provision," meaning "no data, no market."

Penalties: REACH regulations are enforced by the competent authorities of each EU member state, responsible for implementing effective deterrent penalties based on the severity of violations. Penalties may include fines and imprisonment. Since June 1, 2010, member states have been required to report the results of substance registration, monitoring, and enforcement to the European Commission every five years.

Exemptions

Total Exemptions

• Radioactive substances, as they are regulated by other regulations.
• Substances temporarily stored in EU customs or bonded warehouses without undergoing any processing.
• Waste materials.
• Transport of hazardous substances by land, sea, or air.
• Indivisible intermediates.
• Substances exempted for defense purposes.

Exemptions from the obligation to register

• Substances of low concern as listed in Annex IV of REACH.
• Substances listed in Annex V of REACH.
• Neutral ingredients in biocidal products.
• Substances reintroduced into the EU that have already been registered, either as the substance itself or as part of a product.
• Substances for research and development purposes, with an exemption period of up to five years, extendable by another five years if necessary, and applicable only to the quantities needed for research and a fixed list of customers.
• Polymers.
• Medicinal and veterinary products.

SCIP declaration

As part of the European Union (EU) Waste Framework Directive (WFD) (2008/98/EC), the European Chemicals Agency (ECHA) has established a database for storing safety use information of Substances of Very High Concern (SVHC) present in articles or complex objects placed on the EU market. It is referred to as the Substances of Concern In articles, as such or in complex objects (Products) (SCIP) database. Since January 5, 2021, manufacturers, importers, and distributors are obligated to submit information to the database for products containing SVHCs above 0.1% (by weight). As of May 2022, the database contains over 7.6 million entries. ECHA outlines three objectives for this database:

• Reduce waste containing harmful substances by promoting alternatives to SVHCs in articles entering the EU market.
• Enhance transparency of product composition to improve waste management operations.
• Enable monitoring of SVHCs in articles to take appropriate actions at any stage of the article's lifecycle, including the waste stage.

More Information

International Regulations > RoHS

International Regulations > Halogen Free

Reference：

ECHA REACH SVHC