Category: CE Marking

October 2023

As the energy storage market grows rapidly, the European Union has been updating its regulatory framework to address environmental and safety challenges, particularly in battery usage. With the recent replacement of the 2006/66/EC Directive by the new EU 2023/1542 Regulation, there are significant changes for companies dealing with battery products, including those in stationary battery energy storage systems. Here, we explore the main differences between these two regulations, focusing on compliance dates, impacted categories, and the implications for current and future products.

1. Scope of Coverage: From Directive to Regulation

The 2006/66/EC Directive primarily targeted the collection, recycling, and disposal of batteries. In contrast, EU 2023/1542, enacted on August 17, 2023, as a Regulation, enforces a uniform law across EU member states, eliminating the variance that existed under the Directive’s framework. This direct application across all countries represents a significant shift, as companies must comply with a single, stricter standard, which leaves less flexibility but ensures uniformity in compliance.

2. New Product Categories and Broader Application

Under EU 2023/1542, battery categories have been expanded to include a wider range of battery types, focusing on the full lifecycle impact. For stationary battery energy storage systems, this regulation applies more comprehensively across production, usage, disposal, and environmental impact than the 2006 Directive, which primarily focused on collection and recycling. This shift means that producers, importers, and distributors are now responsible for a broader scope of compliance measures.

• Effective Date for Compliance: August 2025 for most new battery products, including stationary energy storage systems.
• Expanded Categories: Alongside portable, automotive, and industrial batteries covered by the previous Directive, the new regulation specifically addresses “stationary energy storage” batteries, bringing these systems under stricter scrutiny.

3. Circular Economy and Sustainability Focus

EU 2023/1542 introduces specific sustainability measures that go beyond the recycling mandates of the 2006/66/EC Directive. The new regulation requires companies to implement a circular economy model, mandating that battery producers focus on sustainable sourcing, efficient recycling processes, and the responsible sourcing of raw materials.

• Battery Recycling and Collection Targets: Under the new regulation, manufacturers must meet progressively increasing collection and recycling rates. For stationary energy storage batteries, targets for material recovery (such as lithium, cobalt, and nickel) are set for 2025, with further increases mandated by 2030.
• Carbon Footprint Declarations: This new requirement will take effect in July 2027, mandating all manufacturers, including those producing stationary energy storage systems, to disclose the carbon footprint of their products. This disclosure supports the EU’s climate goals by emphasizing energy-efficient production.

4. Enhanced Safety and Performance Standards

One of the critical aspects of EU 2023/1542 is its emphasis on safety and performance standards, which will have a particular impact on high-capacity battery systems like those used in stationary storage. Unlike the older Directive, which did not specify performance metrics, the new regulation includes requirements for battery durability, capacity retention, and safety testing.

• Timeline: These standards will begin to take effect in 2026, with full compliance expected by 2028 for all new stationary energy storage systems sold within the EU market.
• Article 12
• Safety of stationary battery energy storage systems
• 1.   Stationary battery energy storage systems placed on the market or put into service shall be safe during their normal operation and use.
• 2.   By 18 August 2024, the technical documentation referred to in Annex VIII shall:

(a)

demonstrate that the stationary battery energy storage systems are compliant with paragraph 1 and include evidence that they have been successfully tested for the safety parameters set out in Annex V, for which state-of-the-art testing methodologies shall be used. The safety parameters shall only apply in so far as a corresponding hazard exists for the stationary battery energy storage system in question when it is used under the conditions envisaged by the manufacturer;

(b)	include an assessment of possible safety hazards of the stationary battery energy storage system that are not addressed in Annex V;

(c)	include evidence that the hazards referred to in point (b) have been successfully mitigated and tested; state-of-the-art testing methodologies shall be used for such testing;

(d)	include mitigation instructions in case the identified hazards could occur, for example a fire or explosion.

• The technical documentation shall be reviewed if a battery is prepared for re-use, prepared for repurposing, remanufactured or repurposed.
• 3.   The Commission is empowered to adopt delegated acts in accordance with Article 89 to amend the safety parameters set out in Annex V in view of technical and scientific progress.

5. Digital Product Passports for Battery Traceability

To improve traceability and responsible end-of-life handling, the new regulation introduces Digital Product Passports for each battery. These passports will record essential information on battery composition, production origin, and recycling details, enhancing transparency across the supply chain and enabling more efficient recycling processes.

• Compliance Timeline: Digital product passports will become mandatory by 2026 for high-capacity industrial and stationary energy storage batteries.

6. Implications for Existing Stationary Battery Energy Storage Systems

If you currently manufacture, import, or sell stationary energy storage systems in the EU, the new regulation requires several adjustments. Unlike the 2006 Directive, where compliance was often a matter of basic recycling participation, the new regulation holds each part of the supply chain accountable for eco-friendly production, responsible end-of-life disposal, and detailed reporting.

7. How We Can Help

Navigating these regulatory changes can be challenging, particularly when integrating these requirements into your existing products and operations. Our consultancy specializes in regulatory compliance, product assessment, and sustainable design integration for energy storage solutions. With our expertise, we can guide your business through the updated compliance framework, ensuring that your stationary battery energy storage systems align with EU 2023/1542 requirements efficiently and cost-effectively.

Reach out to us for a personalized compliance assessment to secure your market position and lead in sustainable, compliant energy storage solutions.

As the EU raises the standards for battery production and disposal, staying informed and prepared is more crucial than ever. Proactively adapting to these new standards will ensure your business’s smooth transition and long-term success in the EU market

The CE mark is an essential symbol for products marketed in the European Economic Area (EEA). It stands for “Conformité Européenne” and indicates that a product complies with relevant EU safety, health and environmental legislation. The logo consists of the letters “C” and “E” in a stylized design that always has the same proportions.

Why is CE marking important?

CE marking ensures that products are freely tradable within the EU market, without each member state applying its own rules. It is a guarantee that a product meets the strict requirements of the EU. Without CE marking, a product can be rejected from the European market, which can have major consequences for companies.

How do you recognize the right CE mark?

An important nuance is the difference between the true CE mark and the similar “China Export” logo, which is often confused with the official CE mark. By the way, there is no evidence that “China Export” is really a thing, popularly named as such. The real CE mark has specific dimensions, while the China Export logo looks very similar but does not comply with EU directives.

Conclusion

It is crucial to know what a CE mark looks like and what rules are associated with it. Companies must make sure they use the correct logo to comply with European regulations and avoid having their products rejected from the market.

Notified Body

When entering the European market with your product, obtaining CE marking is a crucial step. This marking shows that your product complies with EU safety, health and environmental protection legislation. But whether you need a Notified Body depends on several factors, such as the product category and associated risks. A Notified Body is an organization designated by the European Commission within Europe authorized to perform conformity assessments according to the relevant directives.

Self CE certification

For some products, self-certification is sufficient. This means that as a manufacturer, you can self-declare that your product meets the required standards, after going through the necessary tests and compiling the technical documentation. Products such as simple household appliances and toys can often obtain CE marking without the intervention of a Notified Body, provided the risks are low and the standards are clearly defined. In such cases, you save not only time but also the costs associated with external review.

When do you need a notified body?

However, for products with higher risks, the role of a Notified Body is indispensable. Consider medical devices, explosion-proof equipment, and certain machinery. These products require a more thorough and independent assessment to ensure that they meet strict safety standards. The Notified Body conducts inspections, tests and audits, and issues the necessary certificates. This process provides additional assurance to both the manufacturer and the end user that the product meets all legal requirements.

What notified bodies are there?

Some well-known Notified Bodies are TÜV Rheinland, BSI Group, SGS, Dekra, and UL. These organizations have the expertise and authority to conduct detailed inspections, tests and audits to ensure that products meet strict EU standards.

The 4-digit code assigned to a Notified Body is a unique identifier used to identify the specific organization that performed the conformity assessment. This code is often displayed next to the CE mark on a product, indicating that an approved Notified Body was involved in the assessment and certification. For example, if you see a product with the CE mark and the code “0123,” it means that the Notified Body with the code 0123, in this case TÜV SÜD, approved the product. This system ensures transparency and traceability in the conformity assessment process.

For more information on Notified Bodies and their specific roles, please visit the NANDO website. Here you will find a complete list of recognized Notified Bodies and their respective 4-digit codes, as well as detailed information on their competencies and certification areas.

Conclusion

In short, engaging a Notified Body is not always mandatory, but essential for products with higher risks or complex regulations. It is important to know and understand the specific requirements for your product category. By determining early whether a Notified Body is needed, you can take the right steps to ensure that your product enters the European market safely and legally. Whether you choose self-certification or external assessment, complying with CE regulations is a fundamental part of building trust and success in the European marketplace.

Within Instrux, we have years of experience when it comes to working with Notified Bodies. Looking for someone to handle the contact for you? Or do you want to make sure you need one? If so, please contact us.

What is CE marking?

CE marking stands for “Conformité Européenne” and shows that a product complies with EU legislation. The marking is required for several product categories and is a manufacturer’s declaration that the product meets EU safety standards. It is important to note that the CE mark is not a quality mark, but rather a compliance marker, meaning that the product was evaluated before it was put on the market.

When is CE marking Mandatory?

CE marking is required for several product categories, including toys, electrical equipment, medical devices, machinery, personal protective equipment, construction products and more. Each of these categories has its own specific guidelines and standards that must be met before a product can bear the CE mark. Depending on the category, the process for obtaining CE marking can vary, from self-certification to mandatory independent assessment by designated bodies. A good way to see if CE is mandatory is to use the RFO website. Because of their easy system, that’s how you know if you are required to have CE. This system can be found here.

Briefly, it applies to the following products, among others:

• Machinery
• Medical devices
• Construction Products
• Toys
• Personal protective equipment
• Electrical, electronic and energy related products
• Medical devices
• Measuring and weighing equipment
• Transportation Equipment

The Consequences of Noncompliance

Failure to meet CE marking requirements can lead to significant consequences. This can range from fines and recalls to an outright ban on the sale of the product in the EEA. These consequences can not only cause financial damage, but also severely damage a company’s reputation. CE marking, then, is not something to be taken lightly; it is a crucial aspect of product compliance that requires serious attention.

The importance of compliance

Compliance with CE marking requirements is not only a legal necessity, but also an essential part of ensuring the safety and reliability of products within the EEA. Instrux provides expertise and support in navigating the complex world of product compliance, from interpreting legislation to supporting the certification process. By ensuring your products are compliant, you are investing in the safety of your customers and the integrity of your brand.

Let’s get specific

Instrux is all about products, and that means we look at things in detail, especially when it comes to insurance. One specific component we cannot overlook is product liability.

In our world, where we deal exclusively with products, it is crucial to understand how product liability fits into the bigger picture of business insurance. Therefore, product liability insurance is often part of the many business liability insurance policies that can be purchased.

What exactly is product liability?

Let’s face it: in the world of production and sales, something can always go wrong. Product liability places responsibility on manufacturers and sellers when their products cause damage. Whether it is a faulty coffee maker or a mischievous toy robot, the legal implications are real. The idea is simple: if your product gets someone into trouble, you as the producer or seller are liable. This forces companies to think seriously about the safety and quality of what they put on the market.

What do you need the insurance for?

Imagine: someone uses your product and things go completely wrong, from injury to damage, and suddenly you have a fat claim on your hands. As a company, you are obviously not waiting for this, but according to article 6:185 of the Civil Code in the Netherlands, a manufacturer is liable for damage caused by a defective product. So what now, you have to start paying immer by law.

Fortunately, there is then insurance that can assist. They will take on this claim and ensure that you as a company remain indemnified. Of course, they are not doing this out of the goodness of their hearts, as you have to pay a premium that is usually based on your turnover and industry.

But beware, there are snags

As with any insurance, there are points of interest. These show up in the fine print found in your insurer’s terms and conditions. As a result, you may think you are covered for damages when in reality you are not. So always carefully read terms and conditions of your insurance. Also, it is always advisable to hire an advisor for tricky insurance policies. At Instrux we always recommend Zuiderhuis, they can give expert advice the different insurance policies that may be useful for a business.

Without CE, no insurance

In addition to the fine print that sometimes makes you wonder, there is also a big letter that should be clear: no CE, no insurance. And by this we do not mean that you have to have CE on every product, as this is not allowed. No, we would like to emphasize the need for valid CE documentation. In fact, before they decide to pay out, the insurance company will ask you if they can review your documentation. If they subsequently discover that this documentation was incomplete or invalid at the time of the claim, you will still have to pay for everything out of pocket.

Betrap jij nu jezelf erop dat je al enige tijd premie betaalt, maar niet zeker weet of je wel echt dekking hebt bij schade omdat je CE documenten nooit gecontroleerd zijn? Neem dan vrijblijvend contact met ons op, dan helpt Instrux jou met het zorgen van een dekkende verzekering.

Enter the new year safely

With the approaching New Year’s Eve, many are looking forward to an evening of celebration, drinking and fireworks. Unfortunately, however, we are seeing a worrisome increase in injuries during these festivities. Of the 1253 cases during the turn of the year 2022-2023, as many as 25% resulted in (permanent) eye damage. In this blog post, we take a critical look at the CE marking of fireworks glasses, a seemingly simple accessory that is crucial to protecting our eyes.

Requirements for Fireworks Glasses

Fireworks glasses must meet strict requirements to be considered safe. The EU Type Examination Procedure is essential here. This means that a Notified Body, a notified body, has reviewed the documentation before fireworks glasses with a CE mark can be placed on the market. However, these agencies are located only within the EU, resulting in significant costs.

In addition, fireworks glasses must meet specific standards, including EN 166 and EN 167. Without this approval, these glasses may not be sold as protective against fireworks. Unfortunately, despite these clear guidelines, we see several festival glasses, including those with lights, being sold as “fireworks glasses” without adequate compliance documents. A critical note is in order here, especially with regard to popular platforms such as globe, which sometimes fail to ensure the security of their customers.

So as a consumer, you need to make sure you inquire about the certifications of the glasses. Before you know it, you put a regular piece of plastic on your face, potentially putting you at even greater risk.

List of Safe Products

To give you and your loved ones peace of mind during the New Year, we at Instrux have compiled a list of fireworks glasses that we have determined meet safety requirements. With these, you can go into the New Year with confidence, knowing that your eyes are well protected.

• Outlook fireworks goggles
• Climax Fireworks Goggles
• Uvex Fireworks Goggles

𝐕𝐞𝐫𝐤𝐨𝐨𝐩 𝐣𝐢𝐣 “𝐯𝐮𝐮𝐫𝐰𝐞𝐫𝐤𝐛𝐫𝐢𝐥𝐥𝐞𝐧” 𝐞𝐧 𝐛𝐞𝐧 𝐣𝐞 𝐯𝐚𝐧 𝐦𝐞𝐧𝐢𝐧𝐠 𝐝𝐚𝐭 𝐣𝐞 𝐨𝐨𝐤 𝐨𝐩 𝐝𝐞 𝐯𝐞𝐢𝐥𝐢𝐠𝐞 𝐥𝐢𝐣𝐬𝐭 𝐡𝐨𝐨𝐫𝐭? 𝐒𝐭𝐮𝐮𝐫 𝐨𝐧𝐬 𝐝𝐚𝐧 𝐞𝐞𝐧 𝐦𝐚𝐢𝐥 𝐨𝐩 𝐢𝐧𝐟𝐨@𝐢𝐧𝐬𝐭𝐫𝐮𝐱.𝐧𝐥 𝐞𝐧 𝐧𝐚 𝐛𝐞𝐯𝐞𝐬𝐭𝐢𝐠𝐢𝐧𝐠 𝐯𝐨𝐞𝐠𝐞𝐧 𝐰𝐞 𝐣𝐞 𝐭𝐨𝐞.

Would you like Instrux to support you in certifying your “fireworks goggles,” safety glasses or other Personal Protective Equipment? If so, please contact us.

What is a Technical File?

The technical file: it may sound like a bundle of papers and documents, but it is the most important document when it comes to obtaining CE marking for your products. In this article, we take a closer look at what all must be in a technical file, according to various CE directives and regulations.

What should be in the technical file for consumer electronics/items?

Each guideline may differ on exactly what should be in a file. In general, though, the following points are always required by EU law:

(a) a general description of the electrical equipment;
(b) design and manufacturing drawings as well as diagrams of components, parts, circuits, etc;
(c) adequate risk analysis and assessment.
(d) descriptions and explanations necessary for understanding those drawings and diagrams and the operation of the electrical equipment;
(e) a list of the harmonized standards applied in whole or in part
(f) the results of design calculations, investigations, etc., performed; and
(g) test reports.
(h) declaration of conformity

Compilation of the technical file is a crucial step in the CE marking process, namely step 5. This brings together all the information needed to demonstrate regulatory compliance. Should you need help with step 5, Instrux can provide excellent assistance with that. You can request assistance through our intuitive order page, or through our contact page.

Access to Technical File: Important for Market Supervision

When there are doubts about the safety of a product or compliance with directives, the technical file should be immediately available to market surveillance authorities. If the product is actually found to be unsafe or non-compliant, authorities may even demand that the product be removed from the market through a product recall.

Keeping the technical file is serious business. Generally, the manufacturer or importer must retain it for 10 years. Market regulators within the European Union can demand a copy of the technical dossier even many years after the product is launched. However, clients do not necessarily have to have access to this file; it is not required to be disclosed.

Do I need a declaration of conformity?

A declaration of conformity is required to show that the product complies with European safety standards and legislation, specifically CE legislation. This is important because otherwise the product may not be sold in the European market. It is also a way to build trust with customers because they can be confident that the product is safe and compliant with regulations.

Many products we use in our daily lives require an EC declaration. Consider small electrical devices such as, cell phone chargers, headphones, shavers and other portable electronics. But don’t forget that toys for children and babies are also subject to this. For example: soft toys, puzzles, blocks and other educational toys.

Important points in a declaration of conformity

A declaration of conformity contains essential information about the product, manufacturer and applicable standards. Key components to be included in the statement include:

• The name and address of the manufacturer
• The description of the product
• The European guidelines used
• The standards and/or technical specifications used to assess the product’s compliance with safety standards
• Information on the testing procedures performed to determine whether the product is safe
• Date and signature of authorized person within the organization

What are the dangers of not having this statement?

The dangers of not having a declaration of conformity or having an incorrect declaration of conformity are great. First of all, it is illegal to sell products without having a declaration of conformity. In addition, having an incorrect declaration of conformity can lead to unsafe products and thus risks to users’ health.

Another important factor that can affect not having a declaration of conformity is the risk of liability for the manufacturer or seller. If a product does not comply with applicable regulations and an accident or incident occurs with the product, the manufacturer or seller may be held liable for any damages or injuries. This can lead to financial losses and reputational damage for the company.

Therefore, it is critical for companies marketing products to have a declaration of conformity indicating that the product complies with applicable regulations and is safe for use. This can help reduce liability and increase consumer confidence in the product. Therefore, pay close attention to which party you choose to prepare your declaration of conformity. It seems like a simple document that can do little harm, but in reality, this is a very different case.

Do you now feel that you would like an expert to prepare the compliance statement for you? Then simply apply here for a declaration of conformity prepared by experts at Instrux.

What is a model number?

A model number is a unique code assigned to a product that distinguishes it from other products. Think of it as your product’s ID card: unique, distinctive and informative. This number is often used by manufacturers and distributors to catalog and track their products.

Model numbers are essential for multiple aspects of product management and compliance:

1. Identification and Tracking: Model numbers help quickly identify products, especially in cases where titles or descriptions may overlap.
2. Quality assurance: In case of recalls or quality checks, specific batches can be easily traced.
3. Market confidence: Customers and regulators see model numbers as a sign of professionalism and legitimacy. This increases trust and credibility.
4. Compliance: For products covered by certain standards (such as CE marked items), a model number is part of the mandatory information to meet compliance requirements.

Is a Model Number Required?

For certain product categories, especially those subject to strict safety standards, the use of a model number is not only recommended, but required by law. This is especially true for products that require CE marking. The CE mark, which stands for “Conformité Européenne,” is a declaration that the product complies with EU regulations. Having a unique model number is part of this compliance because it shows that each product is traceable and identifiable.

As an e-commerce business owner, it is important to understand when and why a model number is needed. For products covered by specific regulations, such as electronic equipment, toys, or medical devices, it is not just a matter of best practice, but a legal requirement.

How to Invent Your Own Model Number

Creating an effective model number is an important part of product management and compliance. Here is a simple step-by-step guide to help you come up with your own model numbers.

Step-by-Step Guide

1. Start with a Unique Base: Choose a unique set of letters and/or numbers that represent your company or product line. This forms the basis of your model number.
2. Add Product Specific Details: Consider adding numbers or letters that indicate specific product features, such as size, color, or version.
3. Keep it Simple and Clear: Avoid overly long or complicated codes. A model number should be easy to read and remember.
4. Consistency is Key: Ensure a uniform structure in all your model numbers. This facilitates identification and tracking.

Importance of a Model Number Register

Keeping a record of your model numbers is essential. This not only helps organize your products, but also provides an easy reference in case of compliance checks or customer inquiries.

Tips and Best Practices

• Be Unique: Make sure each model number is unique to each product.
• Plan Ahead: Think about how your model numbering system can grow with your product line.
• Check for Duplicates: Before assigning a model number, check that it is not already in use.

Now that you know how to come up with your own model number, it is important to understand that self-conceived model numbers can sometimes lead to non-valid documentation. In the next section, we will explore this risk and possible solutions.

Proprietary Model Number and Use of External Reports and Certificates

Designing your own model numbers for your products may seem practical, but it presents significant challenges, especially when it comes to linking them to existing reports and certificates.

Non-Compliance Risks.

One of the biggest problems with not being able to link your unique model number to official documentation is the risk of non-compliance. This is because your product is no longer traceable to the matching documentation. This can cause your documentation to be considered noncompliant. After all, an inspector cannot verify that you really have the same product as on the reports. Indeed, counterfeiting in appearance is very common in these times.

A simple document provides the solution

For e-commerce entrepreneurs navigating the complexities of model number management and compliance, Instrux offers an effective and easy-to-use solution with their Declaration of Equivalence template.

The Role of the Declaration of Equivalence.

The Declaration of Equivalence is an important document that, although unofficial, is widely accepted by inspectors and regulatory authorities. It serves as proof that a product meets the relevant standards, even if the model number differs from the original documentation.

Use is really very simple, you only need to receive the data and a signature from the owner of the documentation. Indeed, in this statement, the owner states that even though the model numbers are different, the products are identical to each other. This statement allows you to use the documentation with the other model number.

How did you get this template?

Again, very simple: just send us an email with a request to share this template. In no time we will have these sent to you so that you too can use your own model numbers while complying with legislation.