Table of Contents
What is the REACH Regulation?
REACH compliance, as known, is based on the REACH Regulation. The acronym REACH stands for “Registration, Evaluation, Authorisation and Restriction of Chemicals.” It is an EU regulation that entered into force in 2007. Since then, the regulation has undergone many amendments due to the enhancement of knowledge related to chemicals.
According to the official website of the European Union regarding Energy, Climate Change, Environment; the aims of the REACH Regulation include:
- Ensuring protection for human health and the environment against the risks posed by chemicals
- Assessing the safety of chemical substances in use in the European Union
- Promoting competitiveness and innovation
- Promoting alternative methods, which are non-animal, for assessment of the hazards of substances.
REACH Regulation applies to all chemical substances including cleaning products, electrical appliances, and clothes. It imposes legal obligations on companies to identify and manage the risks linked to the substances they produce and market in the European Union.
Implementation of REACH
According to the official website of the EU, national competent authorities from EU member states and EEA countries must submit to the Commission a report regarding the operation of REACH and CLP in every 5 years.
As stated earlier, REACH is an acronym for “Registration, Evaluation, Authorisation and Restriction of Chemicals,” and these constitute the key components of it. These are as below:
- Registration:
According to the REACH Regulation, for substances manufactured or imported in quantities of one tonne or more per year, companies need to submit a registration dossier to ECHA, the European Chemicals Agency. In the registration process, companies must identify risks related to the substances or mixtures in question and state what their chemical management includes.
For more information, you can view the web pages of ECHA on registration.
After the registration dossier is submitted to the ECHA, it is evaluated by the ECHA’s authorities and the Member States. This ensures compliance with REACH requirements and helps to prevent the use of substances that pose risks to human health or the environment.
However, companies must pay attention to the correctness of their registration dossiers and report any changes to the information stated in the dossier. According to ECHA, in the evaluation process, the most focused areas are the examination of testing proposals submitted by the registrants, compliance checks of the dossiers submitted by the registrants, and substances’ evaluation.
Under the REACH Regulation, authorisation of certain substances is a must. This authorisation process ensures the proper control of hazardous substances and facilitates the replacement of these substances with suitable alternatives when viable. According to ECHA, the authorisation process has two main objects:
- Ensuring that the risks linked to SVHCs are controlled throughout their life cycle
- Promoting the replacement of SVHCs by suitable alternatives if possible.
If there is an unacceptable risk to human health or the environment from the use of a substance, REACH may place restrictions on its manufacture, sale, and use. The European Union may limit or ban these substances.
ECHA suggests that a restriction may apply to any substance on its own, in a mixture or an article. Substances that do not require registration are also included in this application, such as substances manufactured or imported below one tonne per year.
Steps to Achieve REACH Compliance
The steps to achieve REACH compliance can be listed in the table below:
| Steps to Achieve REACH Compliance | |
| Identifying the substances | The first step to achieving REACH compliance is to identify the substances in question. Companies must determine if the substances they have are subject to REACH and plan their actions accordingly. |
| Collecting data | Companies must collect data regarding the properties and uses of substances, including their exposure scenarios, chemical safety assessments, and risk management measures. |
| Preparing and Submitting the Dossiers | As stated earlier, data collected by companies must be compiled into registration dossiers and submitted to ECHA through the IUCLID software. |
| Communicating Down the Supply Chain | Companies must communicate SDSs and exposure scenarios to all relevant parties in their supply chain. They must provide detailed information on safe use and risk management measures. |
| Monitoring and Updating | Even after the registration process is completed, companies must continue to review and update their compliance status regularly as new information becomes available. It is important to stay informed about regulatory changes and new substances added to the SVHC list. |
What Are The Benefits of REACH Compliance?
It is a known fact that REACH compliance benefits the protection of human health and the environment from the risks of chemicals. One of the studies of ECHA can be given as an example to be precise.
According to this study, which focused on the Socioeconomic impacts of REACH authorisations and dated 2021, authorisation requirements ended up with fewer companies using substances of very high concern (SVHCs). Back in 2021, ECHA published an article where they stated that “Out of 54 chemicals subject to authorisation, the use of almost half has stopped altogether in the EU”. This indicates a direct outcome of REACH authorisation, which leads to enhanced protection for people and the environment. According to this study, workers’ exposure to hexavalent chromium lowered and emissions to ethoxylated nonyl- and octylphenols are projected to decrease by more than %90 in the next years. These outcomes imply that REACH authorisation is beneficial for the enhancement of occupational health and safety, substitution of harmful chemicals, human health and the environment. For details regarding the study, you can see ECHA’s article named “REACH authorisation has positive health and environmental impacts“.
Challenges and Solutions
- Identification of responsibilities
As REACH regulation is very complex, identification of their responsibilities may be challenging for the companies.
ECHA held a webinar named “REACH 2018: Know your portfolio and start preparing now” in 2018. This webinar focused on how companies determine their responsibilities and plan their registration process. According to Catherine Cornu, one of the webinar speakers, the first steps for companies can be as below:
- Portfolio
The first thing to do for REACH compliance is to know what substances the companies use. They may be substances on their own, substances in mixtures or substances released from articles.
- Identifying substances
After the used substances are identified, it comes to the determination of the composition and type of them. In this process questions such as “Are they mono-constituent, multi-constituent or UVCB?” must be answered. Companies should also determine the names and identifiers, which are EC number and CAS number, of their substances.
- Determination of registration obligations
After the first two steps are complicated, the related registration obligations can be determined. In this part, there are three questions to ask:
– Does the company need to register the substance? Are they a manufacturer, an importer into the EU, an only representative, or a producer or importer of an article from which a substance is released?
– Does the substance require registration? Or does it affect any exemptions?
– Does the company reach the 1 tonne per year threshold? To answer this question, companies must calculate their volume for the calendar year using a 3-year average if they manufactured or imported during the last 3 years. And they must also do a separate calculation for intermediates under strictly controlled conditions.
These three steps suggest if the registration is needed and helps to determine your company’s obligations. Before you start the registration process you can check out the ECHA website to see which substances have already been registered or read support material for details.
- Understanding the information needs
According to Javier Sanchez Saez, one of the speakers in the webinar, the information below is always a must in the registration process:
- Identification of the substances
– Analytical information - Information on manufacture, use and exposure
– All uses in the life-cycle, from manufacture to waste - Physico-chemical information such as boiling point, vapour pressure, granulometry…
- Classification and labelling
The extra information needed for 1-10 tonnes/year are:
• Toxicological information such as skin and eye irritation – in vitro
• Ecotoxicological information such as short-term aquatic toxicity on Daphnia.
The extra information needed for 10-100 tonnes/year are:
– Toxicological information such as short-term repeated toxicity and screening for reproductive toxicity.
-Ecotoxicological information such as short-term aquatic toxicity on fish and activated sludge respiration inhibition.Chemical safety assessment.
- Consider the business impact
Companies must compile and assess information on topics such as what information they already have on the substances, usage types of substances, information on the other companies that want to register these substances etc.
After companies complete their portfolio they can examine it and plan their actions accordingly.
- Data Collection:
Gathering data is a time-consuming and costly activity. Preferring collaborative approaches, such as joint submissions and data sharing, can be helpful for companies. This way, they can reduce their costs and efforts regarding data collection. According to Javier Sanchez Saez, before companies generate new data, they can follow the steps below:
- Collect available information
- Share data with other companies (*information will need to be submitted jointly)
- Consider information needs
- Identify information gaps
- Generate new data (*new tests on vertebrates only as a last resort)
- Time and resources
Achieving REACH compliance requires lots of time and resources. Companies must plan their actions and budget accordingly.
- Technical Expertise:
REACH covers many complex technical requirements that require expertise in the field. To navigate these complexities, companies must seek help from experts to complete the process successfully if they do not have expertise in-house. They can also review ECHA’s support pages for details regarding the processes.
- Continuous Monitoring:
Companies must maintain REACH compliance continuously. They need to monitor and update their compliance status regularly to achieve long-term adherence to REACH requirements. In this part, they can follow official websites and social media accounts or rely on their consultants.
REACH Compliance in Turkey
Ensuring compliance with the REACH regulation is essential for functioning within the European Union’s regulatory framework. KKDIK is the adaptation of the REACH Regulation to Turkish legislation. Conducting KKDIK registration is a must for companies that wish to market their product in Turkey. By understanding the requirements and adopting a systematic compliance strategy related to this legislation, businesses can fulfil regulatory duties, boost their market competitiveness, safeguard public health, and promote environmental sustainability.
The challenges mentioned above apply to KKDIK registration as well. If you need help in your KKDIK processes, you can benefit from our KKDIK services. You can also check out our digital solutions to make the process more effective for your company.
Contact us for more information and support.
Frequently Asked Questions-FAQ
“REACH compliant” means that a chemical substance or product is compatible with the regulations of EU REACH (Registration, Evaluation, Authorization and Restriction of Chemicals).
As the name suggests, REACH requirements are registration, evaluation, authorization, and restriction of chemicals manufactured or imported in quantities of 1 tonne or more by companies. REACH Regulation includes details about these requirements.
RoHS (Restriction of Hazardous Substances) is a directive that restricts the use of specific hazardous substances in electrical and electronic equipment (EEE). REACH is a regulation that applies to the use of all chemicals in products manufactured, imported or sold within the EU. So “RoHS and REACH compliance” means that a certain substance is compliant with both regulations.
While RoHS focuses on specific hazardous substances in EEE, REACH focuses on all chemicals in products, which means REACH regulation applies much more broadly.
REACH compliance testing refers to a series of chemical analyses or laboratory tests. These tests aim to assess a product’s compliance with the EU REACH Regulation. These tests include substance identification, concentration measurement, and comparison to regulations.
Competent authorities may conduct REACH compliance checks occasionally. Companies may also benefit from online tools to verify a supplier’s REACH registration number.
However, the answer to this question varies depending on your role in the supply chain. For a manufacturer, it involves self-assessment, testing, and technical documentation. While for importers and downstream users, it involves supplier declarations, safety data sheets, and communication processes. To better understand your REACH compliance requirements, you can get support from an expert.
REACH SVHC list refers to the Candidate List of substances of very high concern. This list is a compilation of substances identified by the EU under the REACH Regulation.
Candidate List does not automatically ban a substance but it burdens companies in the supply chain with some obligations.