Navigating the Complexities of REACH SVHC Regulations for a Safer Environment

Introduction

Chemical safety regulations have undergone significant evolution, particularly over the last few decades. This evolution has been largely driven by the growing awareness of the potential hazards posed by chemicals to both human health and the environment. The REACH regulations, instituted by the European Union in 2007, represent a landmark development in this field. REACH stands for Registration, Evaluation, Authorisation, and Restriction of Chemicals. The primary goal of REACH is to ensure a high level of protection for human health and the environment from the risks posed by chemicals. It is also aimed at enhancing innovation and competitiveness within the chemical industry.

In-depth Analysis of REACH Regulations

The REACH regulation imposes comprehensive obligations on companies to manage the risks associated with the chemicals they produce and market in the EU. This includes a mandatory registration for all chemicals manufactured or imported in quantities exceeding one ton per year. The registration process involves a detailed evaluation of the substance, including its properties, uses, and potential hazards. Particularly hazardous substances are subject to additional scrutiny, which may include a requirement for authorization before they can be used. The regulation also empowers authorities to restrict the use of certain chemicals that are deemed too risky.

Case Studies

  • Company A’s Compliance Journey: This section could elaborate on how Company A, a mid-sized paint manufacturer, adapted its operations to comply with REACH regulations. Initially facing challenges with the extensive data requirements for registration, Company A invested in a comprehensive chemical management system. This system not only streamlined the compliance process but also improved their overall safety protocols and environmental footprint.

  • Impact of Non-Compliance: In contrast, another case could focus on a textile company that faced significant penalties due to non-compliance with REACH. This company, unaware of the full extent of its obligations under REACH, failed to register a key dye used in its products. The resultant legal actions led to hefty fines and a temporary shutdown of its operations, underscoring the importance of thorough compliance.

Detailed Discussion on Each SVHC

The classification of Substances of Very High Concern (SVHCs) is a cornerstone of the REACH regulations. SVHCs are substances that have properties that might cause cancer, mutate DNA, or impair fertility. They also include substances that persist in the environment and accumulate in living organisms, posing long-term risks to the health of humans and wildlife. For example, a detailed discussion on a specific SVHC, like Bisphenol A (commonly used in plastics), could include its widespread use, the health risks associated with its exposure, and the industry’s response to finding safer alternatives.

Compliance Strategies

Implementing compliance strategies for REACH regulations can be complex but crucial for businesses. This section could provide a step-by-step guide on achieving compliance. For instance:

  1. Inventory and Data Collection: Companies must start by taking inventory of all chemicals used or produced in their operations and gather comprehensive data on these substances.
  2. Risk Assessment and Management: Assessing the risks associated with each substance and developing management plans to mitigate these risks is essential. This could include substituting hazardous substances with safer alternatives.
  3. Documentation and Communication: Maintaining detailed documentation for compliance and communicating safety information along the supply chain ensures transparency and regulatory compliance.

Global Perspective on Chemical Safety

The EU’s REACH regulations have set a high standard for chemical safety, influencing policies worldwide. Countries like Canada, South Korea, and Japan have adopted similar approaches, emphasizing the need for more rigorous chemical management. For instance, South Korea’s Act on the Registration and Evaluation of Chemicals (K-REACH) mirrors many aspects of the EU’s REACH, focusing on the registration and evaluation of chemicals to ensure safety and environmental protection. This section can elaborate on these international parallels, offering a global view of chemical management strategies.

Future Trends in Chemical Safety

The future of chemical safety is likely to see tighter regulations and a shift towards green chemistry. Innovations in biodegradable materials and non-toxic alternatives are gaining momentum. Technological advancements such as AI and big data analytics are expected to play a significant role in chemical assessments, providing more accurate risk analyses and enabling predictive modeling for chemical interactions. This section can discuss these trends, offering insights into how the field of chemical safety might evolve.

Future Trends in Navigating the Complexities of REACH SVHC Regulations for a Safer Environment

Interactive Elements

REACH Regulation Quiz: To test readers’ understanding of REACH, the blog includes an interactive quiz covering key aspects like SVHC identification, compliance requirements, and safety measures. The quiz offers immediate feedback, helping readers gauge their knowledge and learn from any misconceptions.

Infographic on Chemical Registration Process: A visually appealing infographic simplifies the complex process of chemical registration under REACH. It breaks down the steps from data collection to risk assessment and submission, providing a clear and concise overview suitable for both experts and novices.

Interactive Case Study Analysis: The blog features a virtual case study of a company navigating REACH compliance. Readers can interact with different scenarios, making decisions on compliance strategies and seeing the potential outcomes. This element not only educates but also immerses the reader in the practicalities of REACH compliance.

REACH Compliance Checklist Tool: An interactive checklist tool assists companies in self-assessing their compliance with REACH regulations. Users can input specific details about their operations and receive a customized checklist of necessary actions and considerations.

FAQ Section

An FAQ section can address common queries about REACH, providing clear, concise answers. Questions could range from basic ones like “What is REACH?” to more specific queries like “How does REACH impact small and medium-sized enterprises?” and “What are the steps a company should take if its product contains an SVHC?”

  1. What is REACH? REACH is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks posed by chemicals. It stands for Registration, Evaluation, Authorisation, and Restriction of Chemicals.
  2. Who is affected by REACH? REACH affects all companies that manufacture, import, or use chemicals in their business processes within the European Union. This includes not just chemical producers but also companies in various industries like electronics, automotive, textiles, and consumer goods.
  3. What are Substances of Very High Concern (SVHCs)? SVHCs are chemicals that have potentially serious impacts on human health or the environment. They include substances that are carcinogenic, mutagenic, toxic to reproduction, or persistent and bioaccumulative.
  4. What are the obligations of companies under REACH? Companies must identify and manage the risks linked to the substances they manufacture and market in the EU. They must demonstrate how the substance can be safely used and communicate risk management measures to users. If a substance is particularly hazardous, companies must also submit a plan for its substitution.
  5. How does a company register a chemical under REACH? Companies need to gather data about the chemical’s properties, uses, and potential risks. This information is submitted to the European Chemicals Agency (ECHA) through a registration dossier. The registration process involves collaboration with other companies who are registering the same substance.
  6. What happens if a company does not comply with REACH? Non-compliance with REACH can result in substantial fines, legal action, and reputational damage. Authorities in EU member states are responsible for enforcing REACH, and penalties vary by country.
  7. How does REACH impact small and medium-sized enterprises (SMEs)? SMEs are subject to the same REACH regulations as larger companies. However, the regulation recognizes the unique challenges faced by SMEs and provides some support, such as reduced fees for registration and access to guidance materials.
  8. Can non-EU companies be REACH-compliant? Non-EU companies cannot register substances themselves under REACH but they can appoint an EU-based ‘Only Representative’ to fulfill their obligations under the regulation.
  9. What are the steps a company should take if its product contains an SVHC? If a product contains an SVHC in a concentration above 0.1% weight by weight, companies must inform their customers and consumers upon request. They also need to notify ECHA if the total amount of the SVHC exceeds one tonne per year.
  10. Are there any tools or resources to help companies comply with REACH? Yes, there are various tools and resources available. ECHA provides extensive guidance documents, IT tools for submitting registration dossiers, and databases for information on chemical substances. Additionally, many industry associations and consultancies offer support and advice on REACH compliance.

Conclusion

Conclude by emphasizing the crucial role of REACH regulations in promoting safer chemical practices and protecting environmental and human health. Highlight the ongoing need for vigilance, adaptation, and proactive engagement from all stakeholders – including industry, regulators, and the public – in the pursuit of a safer, more sustainable future.

New substances added to the SVHC candidate list

REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) is the European regulation. It addresses the production and use of chemical substances and their potential impacts on both human health and the environment. The regulation also established the European Chemical Agency (ECHA), which manages the technical, scientific, and administrative aspects of REACH.

REACH describes substances of very high concern (SVHC). Producers, importers or suppliers of products that contain SVHC-listed substances are obliged to notify ECHA when:

  • working in Europe, 
  • and the total quantity used is more than one tone per year,
  • and/or the SVHC is present at more than 0.1% of the mass of one produced object.

ECHA has included 6 new substances to the SVHC list for authorization, extending it to a total of 197 substances. Four of the substances, polycyclic aromatic hydrocarbons, were added to the SVHC list with the involvement of the Member State Committee (MSC) after public consultation. More information about the substances and reasons for their inclusion on the SVHC list are informed below. 


Substances added to the SVHC list

Pyrene

Reason for inclusion: Substance is toxic, very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII.

CAS No.: 129-00-0; 1218-52-1

Phenanthrene

Reason for inclusion: Substance is very persistent and very bioaccumulative in accordance with the citeria set out in Annex XIII.

CAS No.: 85-01-08

3-Benzylidenecamphor

Reason for inclusion: Substance is toxic for reproduction (article 57c).

CAS No.: 15087-24-8

2,2-bis(4′-hydroxyphenyl)-4-methylpentane

Reason for inclusion: Substance is carcinogenic (article 57a), toxic (article 57d), very persistent and very bioaccumulative (article 57e).

CAS No.: 6807-17-6

Benzo[k]fluoranthene

Reason for inclusion: Substance is carcinogenic (article 57a), toxic (article 57d), very persistent and very bioaccumulative (article 57e).

CAS No.: 207-08-9

Fluoranthene

Reason for inclusion: substance is toxic, very persistent and very bioaccumuative in accordance with the citeria set out in Annex XIII.

CAS No.: 206-44-0 ; 93951-690



Once a substance is put on the candidate list, producers, importers or suppliers may have to consider legal obligations, described in detail here.

What do you think?

Should the classification be approved or not? What is your opinion? Leave a comment below and let us know.

Thank you for taking the time to read the CheMondis Blog.

Once a substance is put on the candidate list, producers, importers or suppliers may have to consider legal obligations, described in detail here.

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What Do you think?

Should the classification be approved or not? What is your opinion? Leave a comment below and let us know. 

Thanks for taking the time to read the CheMondis Blog. #TEAMCHEMONDIS

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How the European Union regulates Chemicals

What is REACH?

The chemical industry supplies raw materials to almost every other industry and is essential for economic competitiveness. Although essential, chemicals must be properly managed to avoid damage to human health and the environment. Each country or economic union has a specific way of regulating and controlling chemicals. Within the European Union, we have REACH

REACH stands for Registration, Evaluation, Authorization, and Restriction of Chemicals. It is a European Union regulation that addresses the production and use of chemical substances, and their potential impacts on both human health and the environment. REACH came into force on the first of June 2007 and has been described as the most complex legislation in the European Union’s history.

REACH AIM: Improve the protection of human health and the environment from the risks that can be posed by chemicals and promote alternative methods for the assessment of hazards of substances.


How does REACH work?

REACH establishes procedures for collecting and assessing information on the properties and hazards of substances. The regulation has been established by the European Chemicals Agency (ECHA), which manages the technical, scientific, and administrative aspects of REACH.

ECHA receives and evaluates individual registrations for their compliance. Further EU member states evaluate selected substances to clarify initial concerns for human health or for the environment. Authorities and ECHA’s scientific committees assess whether the risks of substances can be managed.

To comply with the regulation, companies must identify and manage the risks linked to the substances they manufacture and market in the EU. They must demonstrate how the substance can be safely used, and they must communicate the risk management measures to the users.

If the risks cannot be managed, authorities can restrict the use of substances. All legal information can be found in “REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL”.

Which companies does REACH affect?

REACH obligations are not only complied with manufacturers of chemical substances, but also to all companies which deal with preparations of the product or articles that contain those substances. For this reason, REACH has an impact on a wide range of companies across many sectors.

If you are an importer of chemical and non-chemical products (such as paints, clothes, furniture, plastic, etc.) you need to ensure that all components should be registered under REACH. Companies established outside the EU are not bound to the obligations of REACH.

The responsibility for fulfilling the requirements of REACH, lies with the importers established in the European Union, or with the only representative of a non-EU manufacturer established in the European Union. REACH applies to substances manufactured or imported in quantities of 1 tonne or more per year, per manufacturer/importer. Some substances are excluded from all or certain aspects of REACH.

Total exemptions

  • Radio-active substances
  • Substances under customs supervision
  • Substances used in the interest of defense and covered by National exemptions
  • Waste
  • Non-isolated intermediates and transported substance

Partial exemptions

  • Substances used in food
  • Medicinal products;
  • Substances included in Annex IV of the REACH Regulation which are known to be safe (such as Nitrogen)
  • Corn
  • Oil
  • Substances covered by Annex V of the REACH Regulation
  • Substances which occur in nature, if they are not chemically modified
  • Minerals
  • ores, ore concentrates
  • cement clinker
  • natural gas
  • liquefied petroleum gas
  • natural gas condensate, process gases and components thereof
  • crude oil, coal, coke
  • Substances occurring in nature other than those listed under paragraph 7, if they are not chemically modified unless they meet the criteria for classification as dangerous according to Directive 67/548/EEC. (Examples include beeswax and some fibers)
  • Polymers (however, monomer shall be registered)
  • Recycled or recovered substance already registered
  • Re-imported substance
  • Substances used for the purposes of product and process-oriented research and development (PPORD) Note: PPORD notification shall be submitted instead.  

Legislation in non-EU countries

A number of countries outside of the European Union have started to implement REACH regulations or are in the process of adopting such a regulatory framework to approach a more globalized system of chemical registration under the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).  

China, the largest chemical manufacturer in the world, has also moved towards a more efficient and coherent system for the control of chemicals in compliance with GHS. Balkan countries such as Croatia and Serbia are in the process of adopting the EU REACH system under the auspices of the EU IPA program.

Switzerland has moved towards the implementation of REACH through partial revision of the Swiss Chemical Ordinance. Turkey has also paved the way to adopt REACH with the new Chemicals Management Regulation.

Transported isolated intermediates

Manufacturers or importers of transported isolated intermediates in quantities of 1 tonne or more per year need to submit a registration dossier (unless the substance is exempted from the registration provisions). The information to be submitted for standard registration purposes is listed under article 10.

However, a registrant of transported isolated intermediates can provide reduced registration information according to article 18 (2) if he confirms that he is manufacturing and/or using the substance under strictly controlled conditions and if he confirms himself or states that he has received confirmation from the user that the substance is used under strictly controlled conditions as described under article 18 (4).

In that case, both the registrant and the users are each liable for their own statement regarding the strictly controlled conditions.

Article 18 on CheMondis

As described in our Terms & Conditions, suppliers must comply with the regulations in order to sell their products on CheMondis. Next to safety and technical datasheets, users can add other relevant information about their products.

Further, suppliers are requested to tick a specific box indicating that their products are regulated by article 18, which covers the registration of transported isolated intermediates. 

Our chemical team constantly re-checks all product information, including the indications about article 18. Nevertheless, CheMondis cannot be heald liable for all information provided by third-party-sellers. 

Thank you for taking the time to read the CheMondis Blog.