Navigating chemical regulations can be a challenge for manufacturers of articles[1] due to their complexity. In the European Union, the REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) framework was designed to promote safer chemicals, protect human health and the environment, and encourage the use of safer alternatives to hazardous substances. Manufacturers are crucial in protecting human health and the environment through compliance with REACH standards.

Let us explore how manufacturers can comply with the regulations set forth by REACH while also ensuring responsible handling of chemicals.

Understanding REACH

Since its inception in 2007, the REACH regulation has been regularly updated to incorporate the latest knowledge about chemicals and their properties. It places legal obligations on various actors in the chemical supply chain, encompassing chemical manufacturing, usage, and presence in articles. Any chemicals that are produced, imported, or used above a certain threshold level require European Chemical Agency (ECHA) registration in accordance with REACH regulations.
The data on these chemicals will be used to assess potential risks and to identify and authorize necessary restrictions on their use.

REACH Obligations for Article Manufacturers

Manufacturers of articles in the EU must identify and manage substance risks, particularly those of High Concern (SVHCs). Article manufacturers must notify the European Chemicals Agency (ECHA) if their products contain substances on the SVHC candidate list in concentrations above 0.1% per weight by substance. This obligation aims to provide consumers with information on the presence of potentially harmful substances in articles.

Communication Along the Supply Chain

Article manufacturers must also ensure that their customers (usually importers or downstream users) are informed about the safe use of articles. This involves providing information on SVHCs and their safe handling.

Duty to Notify

If an article contains an SVHC in a concentration above 0.1% per weight by substance, and the total quantity exceeds one ton per year, the manufacturer must notify ECHA. This requirement is crucial for products with high SVHC content, such as electronics or textiles.

Exemptions and Grandfathering

Some substances are exempt from REACH requirements. Existing substances on the market before a specific date may be covered by a “grandfathering” clause. It is vital for manufacturers to understand if their products fall under these exemptions.

Guidelines for Manufacturers

  • i) Identify: As a manufacturer, you are required to identify all substances the company produces, imports, or uses and determine if they are subjected to registration, authorization, or restriction under the REACH regulation
  • ii) Register substance with ECHA: If the substance is not registered, then the information must be communicated to ECHA through a registration dossier that includes information on the substance’s specifications, uses, hazards, and risk management measures. Some substances may be exempt from registration. For more information on the same, visit ECHA.
  • iii) Documentation: Maintain detailed records of all substances used in articles, using Safety Data Sheets (SDS). SDSs are a widely used system for cataloging information on chemicals, chemical compounds, and chemical mixtures.
  • iv) Supply Chain Collaboration: Ensure effective sharing of necessary information with suppliers, downstream users, and customers through transparent communication and cooperation.
  • v) Continuous Monitoring: The REACH Substances of Very High Concern (SVHC) list is updated twice a year. It is recommended to regularly monitor updates to the SVHC candidate list and assess their potential impact on your products. Alternatively, you can use APA’s Regulatory Watch services to stay ahead of any changes.
  • vi) Invest in Compliance Software: Effective regulatory compliance management is possible with specialized software that streamlines data management, notification processes, and documentation. Such software can significantly reduce the overall cost of compliance and relieve the burden placed on manual resources. APAs has been in the compliance industry for over two decades and is one of the best in class when offering REACH services. Additionally, APA’s compliance management system is backed up by the GreenCheck tool, making it a reliable and efficient solution for organizations looking to stay compliant.

‘Reach’ing out for a sustainable future!

Article manufacturers face complex challenges when meeting REACH regulatory requirements. Compliance with these regulations is a legal obligation and a commitment to ensuring consumer safety and protecting the environment. By understanding their obligations clearly, working closely with stakeholders, and investing in the appropriate tools, manufacturers can confidently navigate the intricate landscape of REACH and build a safer and more sustainable future.
It’s essential to remember that the information we provided is a general overview of REACH requirements for article manufacturers. However, please note that specific obligations may vary depending on the products and the intended markets.

How APA can help

To ensure that you are fully compliant, it’s advisable to seek advice from “APA’s team of regulatory expertsand keep up to date with the latest developments in chemical regulations.

[1] Article an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition

Reach out to our regulation experts on chemical and product regulatory compliances