Ask the Experts: August 16 Edition

Ask the Experts: August 16 Edition

Our regulatory subject matter experts are always helping a range of stakeholders solve compelling regulatory challenges associated with supply chain data management. We compile these insights to help educate compliance professionals through content, webinars and events. They also provide advice to Assent clients. Here are the top five questions our Regulatory team has responded to over the past month.


If a cosmetics company, selling in Europe, wants to add a new ingredient to a product, does the chemical have to be registered under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation?

Valerie Kuntz, Bruce Jarnot & Raj Takhar: 

Under the REACH Regulation, the new ingredient(s) must be registered with the European Chemicals Agency (ECHA) if the company is importing one ton or more of the substances included in the ingredient(s) annually. If the company is importing less than one ton, registration is not required. The company should also ensure that the new ingredient is not restricted under Annex XVII and does not contain a substance of very high concern (SVHC) over the legal threshold.

Beyond the REACH Regulation, the company should be aware of substance restrictions in Annex II and III of Regulation (EC) N° 1223/2009 For Cosmetics. The European Commission provides a searchable database of annex data to ensure restriction data is readily available.


When a company reports substances that are restricted under the REACH Regulation, or makes a declaration of conformity (DoC), are they required to name the specific substance(s), or can they state there is a substance over threshold without naming it?

Raj Takhar:

To comply with Article 33 of the REACH Regulation, companies must provide the substance name when it can be found in an article over the legal threshold, so end users can obtain the necessary safe use information.


What are the CE marking requirements under the Restriction of Hazardous Substances (RoHS) Directive, including placement and standardization of the marking? Are there requirements for putting the marking on packaging, supplemental documentation or individual components?

Valerie Kuntz: 

Article 15 of the RoHS Directive, which introduces the use of CE markings, states that the marking should be placed on the item itself or the data plate. There is no need to also add it to the packaging or individual components. If it is not possible to add the marking to the product due to its size or the material, then the marking can be added to the documentation or packaging instead. Further guidance on CE marking requirements has been provided by the UK government.


If a Made in China sticker is required on sunglasses, but cannot be placed directly on the lens due to quality standards, can a Made in China tag be attached to the frame under United States (U.S.) eyewear requirements? And when selling these glasses in the European Union (EU), how does the EU Unique Device Identification (UDI) System impact manufacturer obligations?

Valerie Kuntz & Raj Takhar: 

U.S. Customs and Border Protection would require either “Frame China” or “Made in China” to be placed in legible English type, printed in permanent contrasting colors on the frame’s temple or temple tip. Given that a removable sticker is allowable, a tag, securely attached to the frame’s temple, should also be allowable.

Corrective glasses and sunglasses fall under the lowest risk class of the EU Medical Device Regulation (MDR), Class I. At this level, self-certification is appropriate. The certification should be created in line with the International Organization for Standardization (ISO) 13485 for EU and U.S. sales, Article 19 of the EU MDR (specifically Annex II and III), and Article 84 and 85 of the EU MDR (which require a defined post market surveillance strategy). Once certification is completed, it is possible to generate a self-signed approval under EU MDR.

Once completed, this process enables the device to be registered in the updated European Databank on Medical Devices (EUDAMED) system, which is expected to go live later this year. Registering under EUDAMED will generate a EU UDI for the product. While registering, be sure to also apply for CE certification.


Can mechanical equipment or other products outside the scope of the RoHS Directive bear the CE marking if it is requested by a customer? If not, is providing a DoC a reasonable alternative, so customers are confident in the manufacturing process?

Raj Takhar: 

Mechanical equipment may be within the scope of the RoHS Directive depending on its use or function. Mechanical equipment is only outside the scope of the RoHS Directive if it functions using kinetic energy instead of electrical currents or electromagnetic fields, or if it is incorporated into a product that does not require the use of electricity to perform an intended function. However, being outside the scope of the RoHS Directive does not mean a product is unable to bear the CE marking. The CE marking represents compliance with over 20 directives, covering a large variety of products, processes and substances beyond those regulated by the RoHS Directive. Bearing the CE marking is often a condition of EU market access, so it is advisable to ensure the technical file for the product is comprehensive.

In terms of business best practices, providing customers with a DoC regardless of a product’s CE certification status is a sound business decision.

For more questions and answers, visit the last edition of Assent’s Ask the Experts blog.

Assent’s regulatory subject matter experts frequently provide actionable insight into regulatory programs through webinars and other events. To learn more, contact