Regulatory challenges faced by companies selling products and chemicals to the EU
To legally place a product on the EU market, it is critical that the company you represent is fully aware of all EU chemical compliance duties to be fulfilled.
Daily business operations like manufacturing or trading often keep companies busy. The field of EU chemical compliance is broad, making it essential to have the necessary capacity for compliance.
While the regulations and authority actions are increasingly strict, a lack of awareness, resources, and expertise about EU chemical and product regulations causes another big challenge for companies selling to the EU.
“Companies operating in the EU find often it difficult to navigate in such a vast regulatory system and determine the exact set of requirements that they need to fulfill. How to face all demands correctly and ensure that the product stays compliant are always the next headaches.”
The EU chemical and product regulation framework is broad and complex. It is common for a product to be subjected to several requirements that companies must comply with to manufacture or trade the product legally in the EU.
For example, companies can be required to do a REACH registration for certain substance(s) contained in the product, provide EU-compliant SDS and label, and/or submit Poison Center Notifications.
EU authorities maintain rigorous market surveillance on both online and offline products, consistently enhancing their monitoring efforts.
Particularly, two main regulations:
- Regulation (EU) 2019/1020 on market surveillance and compliance of products and
- Regulation (EU) 2023/988 on general product safety provides inspection tools to ensure that only compliant products are made available on the EU market.
These measures enable authorities to implement strict enforcement including border inspections and random store checks.
The EU also rolled out a rapid alert system called Safety Gate where all non-compliant products are transparently published on a weekly basis.
EU chemical and product regulatory system is broad and intensive:
- General Product Safety Regulation No. (EU) 2023/988
- REACH Regulation (EC) No. 1907/2006
- CLP: Classification, Labelling & Packing Regulation (EC) No. 1272/2008
- PCN: Poison Centers Notification in accordance with CLP Regulation
- WFD: Waste Framework Directive No. 2008/98/EC
- BPR: Biocidal Products Regulation No. (EU) 528/2012
- RoHS: Restriction of Hazardous Substances Directive 2002/95/EC
- FCM: Food Contact Material Regulation (EC) No 1935/2004
- And many more…
The risks of non-compliance with EU regulations include
- Legal penalties including fines and sanctions
- Reputational damage
- Financial losses
- Criminal liability
- Increased scrutiny
- Market access denial
Based on all the above challenges, we have launched a Pre-study solution to ensure full compliance in the EU market area.
Pre-study of all requirements: many benefits for your company
- Overall knowledge of EU chemical and product regulations.
- Exact investment calculation for compliance and better planning for future financial profits – no money wasted on wrong decisions due to the lack of awareness.
- Exact timeline when the sales and profit accumulation can begin in the EU area.
- Increasing company reputation and trust in the EU market – everything is in order because of raising awareness and full compliance.
- Confidence and certainty when manufacturing and/or trading in EU markets.
What the pre-study covers
The Pre-study service by Chementors is customized according to each specific case.
Generally, the Pre-study includes:
- All possible EU chemical & product regulatory obligations applied to the product in question.
- Evaluation of available data and documents.
- Checklist of missing data and documents to be fulfilled.
- Full plan and procedure for how to comply with the obligations.
- Estimated time and exact budget.
To ensure chemical and product compliance, a professional market Pre-study is an essential long-term investment for your company.
Types of Pre-study
Depending on your project needs, our experts shall assess and customize a Pre-study to meet all possible needs, for example, but not limited to:
- Pre-study on REACH registration obligations
- Pre-study on Biocidal Products Regulation (BPR) obligations
- Pre-study on Food Contact Material obligations
- Pre-study on Substances of Very High Concern (SVHC) in articles
- or even a combined Pre-study of all regulations
Pre-study service: what do you need to provide?
To proceed with the Pre-study, the following documents will speed up the process:
- All available data and documents regarding the product such as composition, overall manufacturing description, safety data sheet, test reports, certificate(s), etc.
- Information on the supply chain of the product
- Expected annual tonnage to EU market
After gathering all the necessary information, our team will take care of the rest.
Don’t risk it. Our pre-study service ensures full EU regulatory compliance.
Enter the EU market confidently with our EU compliance expertise.
Contact us for a free consultation meeting.
