For mixtures placed on the EU market classified with physical or health hazards under GHS, importers are required to complete PCN notification and place the notified UFI on both the SDS and label. PCN compliance should not merely be a reactive measure to avoid penalties—proactive compliance enhances corporate professionalism and strengthens trade competitiveness. Here are five compelling reasons why PCN notification can become your "compliance accelerator."
ECHA Significantly Intensifies PCN Enforcement
Effective January 1, 2025, mixtures must be notified in ECHA's harmonized format. ECHA subsequently launched a PCN enforcement pilot project. The project report revealed that among 1,597 mixtures inspected in the first half of 2025, 19% of companies failed to complete PCN notification as required, and 15% of product labels lacked the mandatory UFI. ECHA has taken action against these non-compliant companies, including fines and even criminal complaints in some cases.
If the current ECHA enforcement pilot represents a "trial run," the upcoming REF-14 project marks the phase of "full-scale implementation." Launched in 2025 with inspections conducted this year, REF-14 aims to enforce classification and labeling of hazardous mixtures, covering consumer products widely available on the market and known to contain hazardous mixtures. Inspections also include notifications submitted to poison centres and mixture SDS.
Member States Conduct PCN Inspections
1. Hungary's appointed body NNGYK is conducting systematic reviews of every PCN dossier submitted. Key review points include:
- Whether component classifications adopt mandatory classifications from Annex VI
- Whether acute toxicity data calculations are correct
- Consistency between toxicological information and classification
- Completeness of toxicological information content
- Components restricted under REACH regulation
- Hungarian language grammar issues
|
|
Example of Review Findings |
Root Cause Analysis |
|
1 |
The mixture was classified as: Acute Tox. 4 (oral) Toxicological data submitted: Oral, Rat, LD50: 120 mg/kg |
GHS classification and toxicological data do not match; based on the data, it should be classified as Acute Tox. 3 (oral). |
|
2 |
The company reported 1,5-naphthylene diisocyanate (CAS No.: 3173-72-6) without specifying particle diameter information. |
This substance is listed in CLP Regulation Annex VI. According to regulations, this chemical exists in two types: one with aerodynamic diameter <50 μm particles below 0.1% (w/w), and another with such particles equal to or above 0.1% (w/w). The two types have different GHS classifications. Specific clarification is required. |
|
3 |
The Member State's appointed body calculated the mixture's ATE value based on the toxicological data of components reported in the toxicological information, and compared the calculation result with the mixture classification. |
The ATE value indicates the mixture falls under Acute Tox. 3 (oral), while the company classified it as Acute Tox. 4 (oral)—a discrepancy requiring correction of the mixture classification. |
|
4 |
The mixture classification reported by the company: Skin Corr. 1A – H314 Description submitted in toxicological information: "Causes skin irritation." |
"Causes skin irritation" describes skin irritation, whereas the mixture classification indicates skin corrosion, not irritation—a contradictory conclusion. |
|
5 |
The company only submitted toxicological data in the toxicological information: ATEmix (oral): 518.13 mg/kg Did not include the description: "Harmful if swallowed" |
CLP Regulation Annex VIII, Part B, Section 2.3 explicitly requires toxicological effect information for the mixture or its components in submissions. While the data implies the corresponding toxicological classification, stating the effect explicitly enables staff to respond more rapidly. |
|
6 |
The company reported the mixture containing lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based (CAS No.: 72623-86-0) at a concentration of 10%, and selected "consumer use" as the product use type. |
Per CLP Regulation Annex I, Table 3.6.2, the generic concentration limit (GCL) for Category 1B carcinogens is 0.1%. Under REACH Regulation Annex XVII, paragraphs 28-30, if this component in the company's mixture is classified as Category 1B carcinogen and exceeds the GCL, the mixture cannot be placed on the market for use by the general public. Therefore, the "consumer use" option must be removed from the notification. |
Upon receiving NNGYK's review results, companies must correct dossier contents and update notifications within the specified deadline. Failure to comply or respond will result in case referral to enforcement authorities for further action. The review findings demonstrate that SDS compliance is a prerequisite for PCN compliance!
2. France sends reminders to companies that have not completed PCN. More stringent regulatory measures may follow.
Protecting Trade Secrets
EU-based importers placing hazardous mixtures on the EU market must complete PCN notification. Regulations require 100% component disclosure in notifications; in practice, at least 90% component information is typically needed to pass automated submission system checks. Consequently, importers require suppliers to provide mixture formulations to achieve PCN compliance, risking trade secret disclosure.
Non-EU suppliers seeking to protect their formulations may appoint a legal entity within the EU to complete voluntary notification. By transferring the notified UFI to the importer, formula disclosure can be avoided.
Leveraging UFI for Mixture Management
Companies may use different trade names for the same product across markets—for example, "Super cleaner" in France, "Cleaning Agent" in Germany, and "Detergent 005" internally. While technical staff may recognize these readily, non-technical colleagues can easily confuse them. Under CLP Article 45 and Annex VIII, mixtures with identical formulations use the same UFI. This UFI characteristic enables clearer internal management: despite varied product names, the formulation remains constant. Companies can use UFI as internal quality control codes to ensure formulations remain synchronized across exported products, marketed products, and archived documents, preventing compliance gaps caused by version confusion. Non-technical departments can also instantly identify identical mixtures through UFI.
Enhancing Professionalism and Trade Competitiveness
Many EU-based importers request notified UFIs from suppliers. Suppliers who prepare documentation in advance and stay ahead of competitors gain trade competitiveness. Suppliers well-versed in EU regulations who proactively prepare compliance measures create a professional impression with importers.
Additionally, Section 1.1 of the SDS requires UFI inclusion. When customs inspect SDS documentation compliance, UFI becomes a focal point. Products with completed PCN notification can pass inspections smoothly.
If your company has any questions about whether your products require PCN notification, please feel free to contact us for consultation at any time! CIRS Group can prepare compliant SDS and labels for you, and provide integrated compliance services including UFI application and PCN notification. If your PCN notification involves Hungary, we can also provide professional Hungarian-language SDS for you, eliminating the hassle of dealing with complex regulatory reviews.
