Guia para fabricantes de maquilhagem: Garantir a compreensão dos regulamentos REACH

Para a maioria dos fabricantes de maquilhagem que exportam para o mercado da UE, o cumprimento da regulamentação do mercado local permite que os consumidores utilizem os nossos produtos com mais confiança. Entre elas, a EU’s REACH regulation is one of the key regulations the cosmetics industry must comply with. Ignoring REACH can result in expensive penalties, product recalls, or even a complete ban from entering the market. In 2023 alone, more than 15% of cosmetic imports were rejected at the EU border due to non-compliance with chemical standards. This guide will give a detailed introduction to the EU REACH regulation and provide practical steps to ensure your products meet its strict requirements.

Understanding REACH: What Makeup Manufacturers Need to Know

What is REACH?

The full name of the EU REACH Regulation is “Registration, Evaluation, Authorisation and Restriction of Chemicals.” It is a regulation that requires the EU to preventively manage all chemicals entering its market, whether they are manufactured, imported, or used in cosmetics and other products.

The EU REACH Regulation officially came into effect on June 1, 2007, and was implemented on June 1, 2008. The REACH Regulation controls almost all products put on the EU market.

Core Requirements of REACH Regulation

Registration: Chemicals produced or imported into the EU must be registered if the annual production or import volume reaches or exceeds 1 ton. When registering, companies must submit relevant chemical information to the European Chemicals Agency.

(ECHA), including the chemicals’ characteristics, uses, safety data, etc., to assess the substances’ risks.

Evaluation: The European Chemicals Agency will evaluate the registration information submitted by the company, review the safety of the chemicals, and determine whether further testing or data supplementation is required. The purpose of the assessment is to ensure that companies fully understand the risks of chemicals and take appropriate measures to control them.

The purpose of the assessment is to ensure that companies fully understand the risks of chemicals and take appropriate measures to control them.

Authorization: For certain chemicals with substances of very high concern (SVHC), companies need to obtain approval before they can continue to use or put them on the market. These substances of deep concern are usually carcinogenic, teratogenic, reproductive toxic, persistent, bioaccumulative, and toxic.

Authorization can only be obtained if the company can prove that the risks of using these substances can be effectively controlled and there are no suitable alternatives.

Restrictions: REACH regulations restrict the use and market placement of certain hazardous chemicals. If the risks of a chemical cannot be effectively controlled by other means, the EU may issue restrictions to ban or limit the use of the chemical.

REACH vs. EU Cosmetic Regulation

The EU Cosmetics Regulation (EC No 1223/2009) governs finished cosmetics, setting out safety, labeling, ingredients, and market access requirements. REACH, on the other hand, applies to all chemical substances, including cosmetic ingredients.

Think of it this way: REACH ensures your ingredients are safe at the source, while the Cosmetics Law rules ensure that the final lipstick or foundation meets consumer safety standards. To enter the market, manufacturers must comply with both regulations.

Step-by-Step Compliance: Registration Process

Step 1: Identify the Chemicals in Your Product

List all ingredients in your formula using INCI (International Nomenclature of Cosmetic Ingredients) names.

Request safety data sheets (SDS) from suppliers to confirm which substances fall within the scope of REACH. If a manufacturer, importer, or other Supplier of a finished product contains a substance of very high concern (SVHC) on the candidate list and its concentration exceeds 0.1% (w/w), it must:

• Ø Notify: If the content is >0.1% and the export volume is >1 ton/year, it is necessary to notify ECHA;
• Ø Information transfer: If the content is >0.1%, information about the substance needs to be transferred along the supply chain;
• Ø Respond to consumer requests within 45 days.

For easy reference, Create a spreadsheet to track ingredients, suppliers, and compliance statuses.

Step 2: Check the SVHC List

ECHA updates its list of Substances of Very High Concern (SVHC) every six months, flagging chemicals with potential risks (e.g., carcinogens or endocrine disruptors). If your product contains an SVHC at a concentration above 0.1% (w/w), you must notify your supply chain and ECHA within six months of its inclusion.

Who needs to make an SVHC notification?

• EU manufacturers
• EU importers
• Non-EU manufacturers (who need to appoint only a representative to make the notification)

Action: Regularly check the ECHA website (echa.europa.eu) to learn about new SVHCs.

The information to be submitted in the notification includes:

• Manufacturer information and contact details
• Substance information and its registration number (if any)
• The tonnage range of the substance
• Description of the substance’s use
• Classification information of the substance

Important information

Information update: If the information in the previous notification changes, such as the adjustment of the tonnage range or the production/import of different articles, it is recommended that the notification be updated in a timely manner.

Public data: Non-confidential data on candidate list substances in articles available to consumers on the EU market will be published on the ECHA website.

Exemption notification: If a manufacturer or importer in the EU has registered the substance for a specific use, you can apply for an exemption notification.

Step 3: Register with ECHA

Submit a dossier for substances that require Registration through ECHA’s REACH-IT portal. This dossier includes detailed data on the substance’s properties, uses, and safety measures. Small manufacturers can reduce costs by joining a consortium to share registration costs with other companies using the same substance.

Example: If you import 5 tons of synthetic fragrances per year, coordinate with your Supplier to ensure they are registered—if you are an importer, do this yourself.

Step 4: Manage Your Supply Chain

Compliance doesn’t stop at your factory. Work closely with your suppliers to ensure that raw materials are REACH compliant.

Ask for a written declaration or test report to confirm compliance. If a supplier cannot provide clear documentation, consider switching to a more reliable partner.

Best practice: Include REACH compliance clauses in supplier contracts to protect your business.

Step 5: Labeling and Transparency

While REACH does not mandate cosmetic labeling (which is the domain of cosmetics regulation), it requires transparency. If your product contains SVHC, clearly inform downstream users and consumers—either on the packaging or in accompanying documentation.

Checklist:

• Are all ingredients tracked? ✓
• SVHC identified? ✓
• Registration completed? ✓
• Supplier verified? ✓

The Impact of Reach Regulations on Our Lives

For consumers, implementing REACH regulations helps reduce the risk of exposure to harmful chemicals. For example, when buying cosmetics, we can use them with more confidence due to the control of REACH regulations because the content of toxic chemicals in them will be strictly limited.

For makeup manufacturers, although compliance with REACH regulations will increase certain costs and management difficulties, it also prompts companies to continue to innovate, develop, and use safer and more environmentally friendly chemicals, thereby enhancing the competitiveness of enterprises.

FAQ

Q: Regulatory jargon and changing requirements overwhelm manufacturers

A: Use ECHA’s free tools, such as REACH Navigator, or hire a regulatory consultant for tailored guidance.

Q: Testing and registration costs are too high for SMEs

Prioritize high-risk or high-volume substances for Registration and explore cost-sharing options through joint submissions.

Q: Suppliers, especially those outside the EU, may lack transparency about their materials.

A: Build long-term relationships with trusted suppliers and request third-party lab reports when needed.

Conclusão

The EU’s REACH regulations are like a tight net that manages chemicals. It protects our health and the environment and promotes the sustainable development of the chemical industry. Through the introduction of this article, everyone has a clearer understanding of REACH regulations.

In future life and consumption, we can also pay more attention to the chemical information in the product and provide more protection for the safety of ourselves and the environment. If you have any other questions about REACH regulations, please ask us.