EU REACH Regulation: The Journey of Chemical Products in the European Market

The safe manufacture and use of chemical products is essential to protecting human health and the environment. The European Union’s REACH Regulation (Registration, Evaluation, Authorisation and Restriction of Chemicals) has been a key framework for the sector since it entered into force in 2007. REACH governs the registration, evaluation, authorisation and restriction of chemicals and places substantial responsibilities on manufacturers and importers.

More importantly, the REACH Regulation is a must for companies wishing to operate in the European market. However, compliance is not only a legal requirement, it also offers great opportunities for businesses in terms of sustainability, innovation and market credibility. In this article, we will discuss the basic principles of the REACH Regulation, the advantages it provides for companies and the compliance processes in detail.

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What is the REACH Regulation and Why is it Necessary?

REACH aims to control the potential risks of chemicals on human health and the environment. In addition, this regulation aims to protect both users and the environment by promoting the safe use of chemicals.

Essential Elements of the REACH Regulation

1. Registration:
   • All chemicals produced or imported within European borders must be registered with the European Chemicals Agency (ECHA) in quantities of one tonne or more per year.
   • This registration process involves the preparation of a comprehensive technical dossier detailing the chemical's properties, hazards and uses. Additionally, the accuracy of this file must be guaranteed by the manufacturer or importer.
2. Evaluation:
   • ECHA analyzes the effects of chemicals on the environment and human health by evaluating the information in the registration dossier. In this process, companies that provide incomplete or misleading information are forced to re-evaluate their products.
3. Authorization:
   • Additional permitting processes apply for high-risk chemicals. The relevant substance can only be placed on the market under certain conditions and for limited periods.
4. Restriction:
   • It is possible for harmful chemicals to be restricted or completely banned in some areas of use. For example, substances that could seriously harm the environment or human health are strictly controlled in this process.

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Advantages of REACH for Business

Compliance with the REACH Regulation not only imposes a legal obligation on companies, but also provides a competitive advantage. Especially companies operating in the European market can increase trust in their brands when they achieve this harmony.

1. Market Access and Growth:
   • REACH compliance is mandatory to sell your products in the EU market. This alignment is therefore key to entering new markets.
2. Consumer Confidence:
   • REACH compliant products are perceived as more reliable by users. Thus, brand value increases.
3. Environmental and Social Responsibility:
   • Promotes environmental sustainability by limiting harmful chemicals. It also increases respect for public health.
4. Supporting Innovation:
   • REACH offers a strong incentive to companies to develop safer and environmentally friendly alternatives.

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REACH Compliance Process

The REACH harmonization process has a complex structure. However, this process can be managed effectively with proper planning and expert support.

1. Technical File Preparation

• In the technical dossier, the physical, chemical, toxicological and ecotoxicological properties of the chemical are stated.
• Information on safety precautions and proper use of the chemical should be provided. Preparing an error-free file in this process ensures that the evaluation phase is completed successfully.

2. Safety Data Sheet (GBF/SDS)

• SDS/SDS is a document that supports the safe use of a chemical. Preparing a REACH compliant safety data sheet is not only a legal requirement but also enables users to manage chemicals correctly.

3. Representation Services

• Manufacturers operating outside the EEA may appoint an Only Representative based in the EEA to enforce importer obligations under REACH on their behalf. Where no sole representative is appointed, the registration obligation lies with the relevant EEA importer.

4. Permit Process for High Risk Substances

• Additional permit applications are required for certain chemicals. In this process, it is necessary to prove that substance use does not harm human health or the environment.

5. Regular Updates

• It is important to update the registration dossier according to regulatory changes and changes in product formulation. In particular, changes to the classification of the chemical should be recorded in the files immediately.

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REACH Compliance and KKDIK in Turkey

Turkey has created a framework that complies with EU standards in terms of chemical regulations. Registration, Evaluation, Authorization and Restriction of Chemicals (KKDIK) legislation is parallel to REACH. Therefore, companies that comply with KKDIK can manage REACH processes more easily.

ONAY As ENGINEERING, we provide professional support in REACH and KKDIK processes. We accelerate compliance processes by providing both technical file preparation and representation services for companies.

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Benefits of Achieving REACH Compliance

1. International Competitiveness:
   • Companies that comply with REACH are one step ahead of their competitors in both local and international markets.
2. Protecting the Environment and Human Health:
   • REACH makes important contributions to environmental sustainability and public health.
3. Operational Safety:
   • Complying with legal regulations increases the operational security of companies.

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ONAY Simplify Your REACH Process with ENGINEERING

ONAY As ENGINEERING, we are here to meet all the needs of your company within the scope of the REACH Regulation. We ensure that your business has a strong presence in the European market with our team of experts in chemical safety, technical file preparation and representation services.

By working with us, you can easily ensure REACH compliance and represent your company safely in the international market.

For the abbreviation of the Regulation, its four pillars and data requirements according to tonnage bands: What is REACH? What does REACH mean?

Position of the Turkish Exporter within the Scope of the EU REACH Regulation

Under the EU REACH Regulation, manufacturers in Turkey cannot register directly; Either the importer in the EU registers or a sole representative in the EU is appointed. In companies with more than one EU customer, the sole representative model generally reduces the total cost. Planning the EU REACH Regulation and KKDIK processes on the same calendar prevents the data cost from being paid twice.

Related pages

• KKDIK consultancy services
• KKDIK glossary of terms
• KKDIK frequently asked questions

Official full text of the regulation: KKDIK Regulation - Official Gazette.

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What is the REACH Regulation? Short answer

REACH is the European Union’s chemicals Regulation No 1907/2006. It was adopted on 18 December 2006 and entered into force on 1 June 2007. Its name stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. Its central change was to place the burden of demonstrating chemical safety on manufacturers and importers. The principle is simple: no data, no market.

REACH Regulation imprint

Official name	(EC) No 1907/2006 — Registration, Evaluation, Authorization and Restriction of Chemicals
Acceptance / entry into force	18 December 2006 / 1 June 2007
Competent body	ECHA — European Chemicals Agency (Helsinki)
Recording threshold	Manufacture or import of 1 tonne or more per year per legal person established in the EU
Four legs	Registration · Evaluation · Authorization · Restriction
Equivalent in Turkey	KKDIK Regulation — separate legislation, requires separate registration

You can refer to our EU REACH registration guide for the registration process, tonnage bands, Only Representative structure and which document to actually submit when a “REACH document” is requested. KKDIK guide for the obligation on the Turkish side and difference between KKDIK and REACH pages have been prepared for the comparison of the two legislations.