For more than two years, companies have been legally obligated to submit product information to the SCIP database of the European Chemicals Agency (ECHA). This obligation is triggered when the concentration of substances of very high concern (SVHC) in their products exceeds the threshold of 0.1 weight percent. Prior to November 23, 2023, there were no penalties in Germany for companies that failed to or submitted inaccurate SCIP notifications. However, this changed with the announcement of the Fourth Amendment to the Chemicals Act in the German Federal Law Gazette. The revised version of § 16f(1)(1) of the Chemicals Act now establishes a legal minimum for the data that must be submitted to the ECHA "immediately after placing the product on the market."
Excerpt from the Chemicals Act 8a.§16f*(1)(1)
Disclaimer: Please note that the text below has been translated from German for your convenience.
We cannot guarantee the accuracy or correctness of the translation.
Therefore, we are not liable for any errors, inaccuracies, or misunderstandings that may arise from the translated text.
For legal advice or clarification, please consult with your legal department or a qualified professional.
"Anyone who, as a supplier of a product within the meaning of Article 3 Number 33 of Regulation (EC) No. 1907/2006, places products within the meaning of Article 3 Number 3 of Regulation (EC) No. 1907/2006 on the market shall provide the following information to the European Chemicals Agency for the database according to Article 9 Paragraph 2 Sentence 1 of Directive 2008/98/EC immediately after placing the product on the market:
- the name of the substance within the meaning of Article 33 Paragraph 1 of Regulation (EC) No. 1907/2006, and if available, its EC number and CAS number,
- the reason for including the substance in the list under Article 59 Paragraph 1 of Regulation (EC) No. 1907/2006,
- the concentration range of the substance in the product,
- the material or mixture category,
- the name of the product containing the substance or the complex object in which an article-as-such is incorporated,
- the article identifier type ,
- the article category,
- the specification of components in the case of a complex object,
- the information whether manufacture or composition of the product or complex object took place in the European Union or not,
- the safe use instructions of the product or complex object."
Implications for Companies in Germany
Under the revised law, it is considered an offense if companies intentionally or negligently fail to submit SCIP notifications correctly, completely, or in a timely manner. As a consequence, fines of up to €10,000 per case can be imposed. The amended law came into effect on November 24, 2023.
opesus Software Solution for SCIP Database Notifications
You may wonder, how is this possible?
The software's advantage lies in its seamless integration with your SAP system. This allows the utilization of already available information to create SCIP notifications. For instance, the material master data includes essential details such as customs tariff numbers or article names, while the bill-of-materials (BOMs) facilitate the structured composition of the product – ranging the smallest components to the products subject to reporting. Once all information is available, IUCLID-compatible dossiers may be generated and sent via system-to-system integration directly to the ECHA SCIP database.
How can you identify products that require a SCIP notification?
opesus SCIP software offers three possible ways for this:
- "The Smooth Path" with SAP EHSM / SAP Product and REACH Compliance
For those using SAP EHSM, opesus SCIP software seamlessly integrates into the system and accesses existing REACH SVHC information. Once the REACH SVHC compliance status of a product is released as "declarable”, opesus SCIP software triggers the creation of a notification.
- SVHC information is available within your SAP system
If you are using SAP without SAP EHSM, SVHC information is usually already stored in SAP material classification. These specific characteristics may include details such as CAS numbers or concentration ranges. Utilizing this data, opesus' software solution automatically identifies affected products across your entire product portfolio.
- SVHC information is only available outside your SAP system
Is SVHC information managed outside your SAP system? No problem! With the help of provided Microsoft Excel templates, SVHC information can be easily uploaded into the opesus SCIP software. From this point, SAP integration takes over again, identifying affected products based on bills of materials and extracting mandatory information from the material master.