On January 23, 2024, the European Chemicals Agency (ECHA) published an update of the Candidate List of substances of very high concern (SVHC). With the addition of five new chemicals, the current Candidate list of SVHC now contains 240 substances.

Additionally, the ECHA has updated the existing Candidate List entry for dibutyl phthalate to include its endocrine-disrupting properties for the environment.

5 new substances added to the Candidate List on 23 January 2024 (ECHA/NR/24/01)

Consequences of the Candidate List

• Under the EU REACH Regulation, the inclusion in the Candidate List brings immediate legal obligations for suppliers of the substance – either on its own, in mixtures or in articles. The obligations include:
  • Communicating on safe use: EU or EEA suppliers of articles which contain substances on the Candidate List in a concentration above 0.1% weight by weight have to provide sufficient information to allow safe use of the article to their customers. If a consumer requests such information, EU or EEA suppliers must provide the necessary details within 45 days of receiving the request.
  • Notifying ECHA: EU and EEA importers and producers of articles have to notify ECHA if their article contains a Candidate List substance within six months after it has been included in the list. 
  • supplying a safety data sheet: EU and EEA suppliers of substances on the Candidate List must provide their customers with an up-to-date safety data sheet.
    
    
• Under the EU Waste Framework Directive, companies must also notify ECHA if the articles they produce contain SVHC in a concentration above 0.1 % (weight by weight). This notification will be recorded in ECHA’s database of substances of concern in products (SCIP).

Our technical experts at API can also help support your transition to this or any other regulatory changes.

The European Commission has adopted a proposal for a Toy Safety Regulation – to replace the TSD – that would apply directly to all Member States. This will better ensure Member States do not impose national technical requirements that go beyond the requirements and/or contradict those requirements.

Two objectives of the Toy Safety Regulation:

1. Increase protection from harmful chemicals: the proposal extends the current ban on substances classified as carcinogenic, mutagenic, and toxic for reproduction to include endocrine disruptors (these are chemicals that affect the endocrine system) as well as chemicals that are toxic to a specific organ or affect the immune, neurological, or respiratory system. It also proposes a wider definition of children’s health to include mental health, wellbeing and cognitive development.
2. Strengthen enforcement: checks along the value chain will be strengthened. All toys, including those sold online, should have a Digital Product Passport with all information concerning compliance with the regulation.

Because of their close contact with food, cookware products carry a higher risk of safety issues than many other consumer products. If an object poses a potential safety hazard to users, product recalls may occur.

Product recalls can be expensive and harmful to a brand’s reputation. They can also have long-term effects on how the company is viewed by the public. To ensure cookware complies with international standards, additional tests may be necessary beyond what can be done during a regular product inspection.

In this blog post, we will explore the international regulations in the EU and U.S. that cookware manufacturers need to be aware of. We will also list the most important cookware safety tests that can help prevent product recalls.

Do you have an internal QA team dedicated to completing technical compliance files? Or do you have simply too many SKUs and suppliers to manage that consolidating compliance documents becomes an administrative burden?

Completing a Technical Compliance File is mandatory for most products that require CE marking in the European Union. Brands and retailers globally are obligated to ensure their products are compliant with market destination standards and regulations.

However, consolidating compliance documents can be a challenging task. Many factors weigh in the complex job of ensuring compliance:

• Stricter regulation and the complexity of the regulation
• Increased specific product safety obligations for providers of online marketplaces
• Reinforced product traceability requirements
• Large number of product documentation from various supply chain stakeholders requiring time and technical expertise

In the European Union alone, 3,412 alerts were issued through Safety Gate in 2023 (as of 10 Jan 2023) for products at risk of non-compliance. It is an increase of 61% compared with the number of alerts issued in 2022.

Source: Safety Gate: the EU rapid alert system for dangerous non-food products

In many instances, it is not easy to handle this internally. This administrative burden also attracts its own risks and the need for technical review, as nearly one-third of the documents evaluated by our experts are found to be non-compliant. Reasons for this include:

• Complexity with keeping records up to date
• Multiplicity of suppliers with different maturity and contacts (to be competitive and ensure effective pricing, brands tend to diversify)
• Numerous documents requiring the right expertise, including knowing the applicable regulations to ask for the appropriate documents
• No dedicated team: Considered a dull, administrative task by brand engineers but cannot be completed by someone without technical knowledge
• Process too slow vs. rotation of collections too fast
• Significant time required
• No proper interface to coordinate document collection and review

API’s TCF (Technical Compliance File) solution

To help relieve many of the compliance pressures that your supply chain currently faces, API presents our dedicated TCF solution. Leveraging over 18 years of experience in this service, our team of local and global experts successfully guided customers through an increasingly regulated market with all the technical compliance files available 24/7 online.

The TCF is a digital ID of your product and its proven compliance with the latest applicable standards and regulations, including:

• Protocoles applicables
• Document validation/rejection
• Validity over time

We offer support with:

• Setting adequate procedures
• Définir le périmètre de conformité pertinent
• Helping establish additional quality and safety criteria that go beyond compliance
• Collecter et valider rapidement un grand volume de documents
• Gathering all the documents in one place (available for 10 years)
• Corrective actions and suggestions for artworks.
• Monitor the relevancy of the scope in the context of regulation changes
• Product Compliance lab testing if missing
• Product Validation Report (PVR).

In addition to our experts’ regulatory guidance, brands appreciate the minimal investment required, enjoy a higher degree of control with our clear digital platform, and are ultimately ready to provide the valid required documentation in cases of custom verification.

A new regulation (EU) 2023/1542 was issued by the European Parliament and the Council on 12 July 2023, addressing the topic of batteries and waste batteries. This regulation amends Directive 2008/98/EC and Regulation (EU) 2019/1020 and repeals Directive 2006/66/EC (with effect from 18 Aug 2025).

Some of the key changes include:

• Non-chemical part: requirements on sustainability, safety, labelling, marking and information to allow the placing on the market or putting into service of batteries within the Union.
  • Labelling and marking of batteries
    • All batteries shall be marked with detailed manufacturing information (including manufacturer name, postal address, web and email address, place of manufacture, date of manufacture…), battery info, hazardous substances present in the battery other than mercury, cadmium or lead, QR code, EU declaration of conformity and CE mark, etc.
  • Carbon footprint declaration for electric vehicle batteries, rechargeable industrial batteries and LMT batteries
  • Performance and durability requirements
    • From 18 Aug 2027, portable batteries of general use excluding button cells shall meet electrochemical performance and durability requirements
      • By 31 Dec 2023, the European Commission will publish measures to phase out non-rechargeable portable batteries of general use.
  • EU declaration of conformity

• Restriction on substances
  

To ensure compliance, API can help test your batteries in our Hong Kong laboratory.

Our experts at API can also help support your transition to this or any other regulatory changes.

Contact our experts now for more information!