Under the European Union’s REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulation,REACH Certification cost in Malaysia the registration of chemicals is required for any substance that is manufactured or imported into the EU in quantities of 1 ton or more per year. The purpose of REACH is to ensure that chemicals placed on the EU market are assessed for their potential risks to human health and the environment.

The minimum quantity thresholds for registration are determined by the amount of substance a company manufactures or imports annually. Understanding these thresholds is critical for businesses in Malaysia and other non-EU countries that are exporting chemicals to the EU. Below is an overview of the thresholds and their implications for REACH compliance.

1. 1 Ton or More Per Year

For any chemical substance that is manufactured or imported into the EU in quantities of 1 ton or more per year, the substance must be registered with the European Chemicals Agency (ECHA). This applies to:

• Substances in pure form: Any chemical substance sold as a standalone product.

• Substances in mixtures: Chemicals that are part of mixtures (e.g., cleaning products, paints, or industrial solutions).

• Substances in articles: Chemicals present in products (e.g., electronics, textiles, or vehicles), if the chemical is released during use or exceeds 0.1% by weight in the article.

2. Substances in Articles (Threshold of 0.1%)

Even if the quantity of a chemical in a product (article) is less than 1 ton per year, if the chemical is classified as a Substance of Very High Concern (SVHC) or if the chemical is released during use, it may still need to be registered under REACH.

• 0.1% by weight threshold: If a substance is present in an article at a concentration of 0.1% or more by weight,REACH Certification process in Malaysia the company must ensure that the substance is registered, provided the substance is intended to be released during the use of the article.

This rule applies even if the article itself is not imported in large quantities, but the chemicals contained within it could pose a risk.

3. Higher Thresholds for Certain Categories of Chemicals

For certain categories of chemicals, such as intermediates (substances used in the production of other chemicals), specific thresholds may apply. Intermediates are generally subject to lower registration thresholds. In these cases, the threshold can be set at 1000 tons per year, depending on whether the chemical is used in closed-loop systems or is isolated during manufacturing.

4. Substances Manufactured or Imported in Smaller Quantities

Substances manufactured or imported in quantities below 1 ton per year are generally not required to be registered under REACH, REACH Certification Consultants in Malaysia unless they are deemed to be of particular concern (e.g., SVHCs) or are subject to specific authorization or restriction processes under REACH.

However, for substances that are potentially hazardous to human health or the environment, even those below the 1-ton threshold, the company may still have obligations to communicate risks through Safety Data Sheets (SDS).

Conclusion

In summary, the key minimum quantity threshold for chemicals that need to be registered under REACH is 1 ton per year. Companies manufacturing or importing chemicals in amounts less than 1 ton are generally exempt from registration, unless the substances are considered hazardous or are part of specific REACH categories (e.g., SVHCs). However,REACH Consultant Services in Malaysia understanding the full scope of REACH regulations is important to ensure that all applicable chemicals are properly registered, especially for those exporting to the EU.