Safety Data Sheets for substances and mixtures are checked for their presence, correctness of format and content, as well as validity. Depending on the member state, different entities may be authorized to carry out such inspections. These are usually organs that control compliance with standards in the work environment, or trade inspections that check the correctness of products being marketed. Depending on who will control the Safety Data Sheet and the competences of such an entity, different sections of the document may be subject to verification. There exist, however, certain convergence points to these inspections, which will not change regardless of their character, and they result from the specific structure and logic standing behind the Safety Data Sheets.

Vital Safety Data Sheet sections - enforcement perspective

As we have indicated in the previous part of the article, Safety Data Sheets may be subject to inspection in various scopes. Therefore, of course, we should have documentation for our products prepared in a way that it meets all the regulatory requirements and in which all sections are fully compliant. However, we can distinguish two sections in the Safety Data Sheets, the correctness of which will be crucial for the consistency of the document. Sections 2 and 3 of the Safety Data Sheet, as we are talking about them here, contain information on the product's classification, labeling and the most important compounds contained in the product (from the regulatory point of view).

Section 2 – a key element of the document

Error-free completion of section 2 of the Safety Data Sheet is the absolute basis for its further development. At this stage, we determine the risks associated with the use of chemical substances and mixtures. Only on this basis are we able to adapt appropriate risk control measures, such as personal protective equipment or product handling methods. The classification of substances and mixtures will also affect the storage considerations, transport rules and waste management.

If we made a mistake at the stage of preparing Section 2 of the Safety Data Sheet, it would affect all other sections of the document, and therefore almost the entire Safety Data Sheet will require reiteration. For this reason, inspections focus greatly on the validity of this SDS part.

Section 2 contains also labeling elements and here again, their incorrect selection, based on an erroneous classification, will have negative consequences. Apart from the issue of the error detected by the inspection, we will also encounter a more serious problem, because it is based on Section 2 of the Safety Data Sheet that the labeling elements and, consequently, the physical label of the chemical product are usually prepared. Section 2 is therefore a particular point of interest for the Trade Inspection. A label developed on the basis of an incorrectly prepared section regarding labeling elements will, in principle, be defective, which may result in, in extreme cases, the need to remove the goods from the shelves and relabel them. This is therefore one of the most difficult and cost-intensive scenarios in the trade of chemical products.

Section 3 - hazardous ingredients

It is true that Section 3 of the Safety Data Sheet does not contain the full composition of the product, but it is required to list substances that are important from a legal point of view. As in the case of Section 2, appropriate development of this element of the Safety Data Sheet will have an impact on:

• Product labeling
• Section 8 of the Safety Data Sheet
• In some cases also Section 14

What is most important, however, is that the classification and labeling elements (i.e. a large part of Section 2) are most often assessed by the inspectors based on Section 3 of the Safety Data Sheet. When developing this part of the document, we must take into account not only its compliance with the regulations, but also that it should form a logical connection with Section 2 of the Safety Data Sheet.

Preparing Sections 2 and 3 of the Safety Data Sheet are the two crucial steps in developing the document, requiring special care and in-depth knowledge of the regulations. Due to the far-reaching consequences of an incorrect preparation, it is always worth seeking help from an experienced specialists. The above considerations will apply to all markets and countries where the Safety Data Sheet is a required document. Regardless of our geographical position, the Safety Data Sheet will be prepared based on a similar logic.

Erronous Safety Data Sheet - consequences

In the previous paragraphs, we have already mentioned that incorrect preparation of the Safety Data Sheet can have a grave impact on business. In the worst cases, it may result in incorrect labeling of substances and mixtures, which entails high costs related to relabelling or collecting the defective goods from the customer, not to mention potential contractual penalties if we are talking about goods marketed in large retail chains. These are, of course, serious consequences, but of a commercial and business nature. However, the regulations also provide for administrative penalties related to failure to comply with the requirements regarding Safety Data Sheets. The amount of the fine for not having a Safety Data Sheet is not always set, but in accordance with Article 126 of REACH and Article 47 of CLP the fine must be: effective, proportionate and dissuasive. Its amount is most often decided by the controlling body, depending on the type and scale of the offense. We must also remember that control authorities have the right to order the suspension of sales or changes to the labeling of products already on the market, and this penalty may be financially more severe than the fine itself. The situation is similar in most European Union member states. Enforcement actions usually result in a list of required changes and corrective actions, only in the next step, if these action plans are not followed, are administrative penalties imposed. The amount of these penalties may vary between countries, but the following examples are worth mentioning as a point of reference:

• In Bulgaria, failure to meet the requirements of Article 31 of REACH (provision of a Safety Data Sheet) is punishable by a fine of BGN 10,000 to 100,000 (approximately EUR 5,000 to EUR 50,000).
• In Cyprus, similarly, a fine of up to EUR 20,000 is provided for violating the provisions of Article 31 of REACH.
• In Italy - the fine for not having a Safety Data Sheet will range from 3,000 to 18,000 euros.
• Slovakia provides for penalties ranging from EUR 16,000 to almost EUR 30,000 for similar failure to comply with the requirements.

The above penalties are therefore severe, especially when compared to the costs associated with the error-free and reliable preparation of documentation. Having appropriate Safety Data Sheets, apart from avoiding problems in the event of inspections, also ensures uninterrupted and continuous market access for our products, which is why it is worth entrusting the SDS development to specialists.