Product compliance - completely new to you? As a term, perhaps yes. But you deal with it - often in a hidden way - on a daily basis. This is because product compliance refers to all business processes that ensure that a product fulfils all legal requirements when it is placed on the market. We can show you simple solutions for getting to grips with this complex topic and support you both with the implementation of a product compliance management system and with our services.
We would be glad to advise you!With athena, you can master your challenges relating to product authorisation and product conformity - in a simple,
structured and up-to-date manner.
By applying the CE marking, the manufacturer or distributor confirms that the product complies with the applicable European directives specific to that product. The CE marking requirement applies to products that fall under CE directives or regulations at the EU legislative level. These include the following product categories: electrical products, construction products, toys, personal protective equipment, machinery, medical devices, pyrotechnics, fertilizers, and batteries.
Products that do not fall under any of these legal requirements are not permitted to have a CE marking.
In order to meet the requirements, the so-called proof of conformity must be provided and conformity must then be declared. We support a wide range of product categories and are at your side to help you implement all relevant regulatory requirements.
A risk assessment must be carried out for every product. The scope and safety aspects to be considered vary depending on the product category and specific requirements. We would be happy to support you with a solution tailored to your product.
With the Poison Center Notification, you report the formulation data of your chemical mixtures to the European Chemicals Agency (ECHA). This clearly links the formulation to the UFI code indicated on the product. The notification is crucial for providing quick and accurate information in an emergency, which poison control centers across Europe need to take appropriate treatment measures.
Poison Center Notification (PCN) must be carried out for all chemical mixtures classified as hazardous due to their physical or health-endangering properties. Mixtures that are classified as environmentally hazardous only, do not need to be reported.
To submit a Poison Centre Notification (PCN), downstream users who manufacture the mixture themselves or importers who import the mixture into the EU must enter the formulation and other product data into the ECHA portal.
We would be happy to check whether you need to submit a PCN and assist you with the notification process.
The UFI code is used to uniquely identify chemical mixtures that have been classified as hazardous due to their physical or health-endangering properties. It consists of 16 alphanumeric characters and has the following format: “UFI: XXXX-XXXX-XXXX-XXXX”.
A UFI can be generated on the website of the European Chemicals Agency or, for Switzerland, on the website of the Chemicals Registration Office.
The CLP Regulation defines the UFI as supplementary information that should be grouped together with the other CLP labeling elements, e.g., near the hazard pictograms. In the case of multi-layer packaging, it is not necessary to affix the UFI to each layer as long as it is included on the inner packaging. When affixing the UFI, ensure that it is clearly visible and remains legible throughout the product's lifetime.
We are happy to assist you in designing your labels and will also check that the UFI code is affixed correctly.
We look forward to your call or message. Feel free to get in contact with us!
Ottostraße 1
63741 Aschaffenburg
Phone: +49 6021 15086-0
Fax: +49 6021 15086-77
info@asseso.eu
Chilehaus A
Fischertwiete 2
20095 Hamburg
Phone: +49 40 32005410