Question 1

What is the EU Safety Gate and how does it relate to product safety?

Accepted Answer

The EU Safety Gate is a rapid alert system for dangerous non-food products in the EU. It facilitates swift communication among member states about products posing serious risks, enabling coordinated recalls and market withdrawals. Using this database to review product recalls of products similar to yours or of risks that have the potential to be found in your products under certain situations, can be helpful input to your product risk assessments and continuous improvement programs.

Question 2

How does the new EU AI Regulation (EU 2024/1689) impact product development?

Accepted Answer

The EU AI Regulation establishes clear rules for the development, use, and sale of AI systems in the EU. It aims to promote trustworthy AI while protecting health, safety, rights, and the environment, affecting how AI-enabled products are designed and marketed.

Question 3

What are the requirements of the EU General Data Protection Regulation (GDPR) for businesses collecting personal data?

Accepted Answer

The GDPR mandates strict guidelines for collecting, processing, and storing personal data of EU residents. Businesses must ensure data security, obtain explicit consent, and provide rights to data access and erasure.

Question 4

What does the EU Packaging and Packaging Waste Regulation (EU 2025/40) entail?

Accepted Answer

The regulation aims to minimize packaging waste, enhance recycling rates, and reduce environmental impact. It sets out requirements for packaging design, material restrictions, and mandates for reusable, compostable or recyclable packaging.

Question 5

How does the introduction of the EU's Digital Product Passport affect manufacturers?

Accepted Answer

The Digital Product Passport initiative requires manufacturers to provide detailed product information digitally, enhancing transparency and facilitating recycling and reuse.

Question 6

What is the EU POPs Regulation and do I need to be concerned about it as a product developer?

Accepted Answer

POPs (Persistent organic pollutants), are substances that persist in the environment and accumulate in living organisms, posing a risk to our health. POPs are regulated globally by the Stockholm Convention and the Aarhus Protocol. These treaties are implemented in the EU by the POPs Regulation. The Regulation prohibits or severely restricts the production, the placing on the market and use of POPs. The use of around 30 different substances and their derivatives or salts are prohibited. As a product business make sure your supply chain is aware of these bans, and in particular, for any soft plastics you have on your products, ensure you or your supplier has tested them for SCCPs.

Question 7

What is RoHS and do I need to comply with it?

Accepted Answer

RoHS compliance is a requirement for all electrical and electronic equipment, and components in the EU and a number of other countries. RoHS stands for Restriction of Hazardous Substances. It is a European directive that restricts the use of certain hazardous materials in electrical and electronic equipment (EEE).

Question 8

What is a Phthalate and are they in my products?

Accepted Answer

Globally, there are a number of regulations that restrict the amount of specific Phthalates that are allowed to be present in different types of products. The most common use of phthalates is in plastics, especially PVC, where they act as plasticisers. A plasticiser is a chemical additive that makes materials softer and more flexible. As an additive they will generally not appear on product or material labels. Another common use is in products that contain fragrances. Phthalates are used as solvents and fixatives to help preserve fragrances and help them to linger. As well as being found in plastics and vinyl products, and products containing fragrances, they are also found in safety glass, lubricating oils, food packaging, adhesives, paints, inks, medical tubing, blood bags, pharmaceuticals, footwear, electrical cables, stationery, nail polish.

Question 9

How do I airfreight products containing Lithium-Metal or Lithium-Ion batteries?

Accepted Answer

It is important to talk to your shipping company or freight forwarder to make sure they are across the requirements for shipping of batteries in or with your products. They will need to be providing a shippers declaration in most instances. The key requirements you will need to be aware of are: 1.All cells and batteries much be tested in accordance with the UN manual of tests and criteria Part III Subsection 38.3 (DGR 3.9.2.6) – and a test summary must be provided to your shipper. 2. For rechargeable batteries, the maximum state of charge for the shipment must be 30%. 3. When Lithium batteries are not installed in the equipment they power, they must be carried on a cargo aircraft (or if they are over the weight restriction). 4. All terminals must be protected against short circuits and inner and outer packaging must be appropriate as per the Wh rating.

Question 10

What do I need to know about the new EU Cybersecurity standards (the EN18031 series), under the Radio Equipment Directive (RED)?

Accepted Answer

These requirements cover connected products. Any devices capable of communicating over the internet, either directly or through other equipment. This includes devices that may handle sensitive data, including personal data, traffic data and location data. Examples include: mobile phones, tablets, laptops, wireless toys, children’s safety equipment (such as baby monitors) and wearable devices, such as smartwatches and fitness trackers. Product Developers or manufacturers must conduct tests focusing on network security, data protection, and the integrity of communication protocols. Devices should be evaluated for their resilience against unauthorized access and potential fraud scenarios.

Question 11

What is Proposition 65 and why should I be aware of it if I sell products in the USA?

Accepted Answer

The Proposition 65 list is a list of a wide range of naturally occurring and synthetic chemicals that cause cancer or birth defects or other reproductive harm. These chemicals include additives or ingredients in pesticides, common household products, food, drugs, dyes, or solvents. Listed chemicals may also be used in manufacturing and construction, or they may be byproducts of chemical processes, such as motor vehicle exhaust. They could also occur as contaminants in commonly used materials. In plastics and electronics, fire retardants, heavy metals and phthalates are commonly used. If you supply products to the USA that may be sold in California, whether through a physical store or online, you need to ensure warnings are provided that relate to any of the chemicals in the list that may be found in your products. The warning must be present at the point of sale and must be in a particular format.

Question 12

What does the new EU Ecodesign for Sustainable Products Regulation (ESPR) mean for businesses selling their products in Europe?

Accepted Answer

The ESPR regulation supersedes the current EU ecodesign directive (2009/125/EC) and introduces additional ecodesign criteria applicable to a broader range of products sold on the EU market. Broadly speaking it says that all products should be designed for extended lifespans and be more easily repairable, upgradeable, and recyclable. This Regulation establishes a framework for the setting of ecodesign requirements that products have to comply with.

Question 13

What types of legislation and standards apply to product safety compliance and how do they relate to each other?

Accepted Answer

In satisfying Global Regulatory Product Safety Compliance requirements, we are exposed to a lot of different terms and pieces of legislation. If we sort things into two basic types of requirements, we can think about: 1. Product safety legislation (also called mandatory requirements) 2. Product safety standards (which are voluntary, but often referenced in the legislation). Product safety legislation defines requirements for product safety that all products in the category must meet to be allowed on the market, as set by governments. This includes regulations, directives, and rules. Product safety standards are developed by private or government standards organisations. They provide technical specifications and guidelines to ensure that products meet safety requirements and best practices. While they are voluntary, compliance with relevant standards is often recognised as a way to demonstrate conformity to legal requirements.

Regulatory and Product Safety Updates

Stay informed with updates on global regulatory changes and product safety trends

New EU Cybersecurity standards (the EN18031 series), to be made mandatory under the Radio Equipment Directive (RED) for CE marking, are now here.

European cybersecurity standards affect developers of connected products.

Global Regulatory Product Compliance Updates

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