Compass to chemical safety – The 9 most important things to know about the distribution of chemical products
As demand for chemical products has increased, new market players (distributors) have emerged who do not yet have any experience or knowledge of the chemical safety regulations that govern the trade (amongst others) regarding these products.
In this article, we will guide you through the most important questions to be answered so that you can start trading chemical products with the knowledge you need.
As a first step, it is important to establish the “status” of the company, which should be determined individually for each product. It logically follows that a firm can have several roles at the same time.
The roles and responsibilities will be determined primarily by where the chemical product is sourced from. In fact, to be truly precise, it will depend mainly on which of the parties involved in the transaction is the real “supplier” of the product and, consequently, which party will be the seller or buyer in the country where the product will be marketed.
This is the first and most important point where even many chemical safety “experts” follow a flawed logic (usually based on a one-sided or on a solely REACH or CLP definition) and wrongly define the responsibilities of the company concerned.
We will not fall into this trap and will use a simple example to illustrate the point:
If you buy a product from e.g. a German company and later want to sell it in any Member State country (for example in Hungary), is the German company the one that puts the product on the market in Hungary first or is it your company?
The correct answer is: it can be either, depending on who organises (pays for) the delivery.
In other words: if the German company transports the product to Hungary, then the Hungarian company will be the “reseller” of the goods purchased, because the German company has already brought the product to the Hungarian market.
If the Hungarian company arranges the transport to Hungary, then they will practically “go to Germany to pick it up”, meaning that the German partner sold the product in Germany and the Hungarian company will be the “distributor responsible for marketing in Hungary”.
We have deliberately not touched on sourcing from a non-EEA country, as this is considered an import and as such, falls under a completely different classification (in fact the company cannot even be classified as a distributor in this case, the status of importer is listed as a separate category in the relevant legislation). This article is not aimed at importers, although the obligations described here apply to them as well (however, they have significantly more obligations and greater responsibilities).
We should also mention that for certain specific product types (e.g. biocidal products), distributors may have additional responsibilities, however, we will not discuss them in this article.
Do not continue reading this article if
because in the above cases the status of your company changes to “downstream user” and you will (may) have completely different chemical safety responsibilities.
You will need the Safety Data Sheet and label draft of the product in the language of the Member State. If the product is classified as hazardous, you will also need a PCN notification (not to be confused with other authorisations or REACH registration), to start marketing. Only specific products such as biocidal products or pesticides need to be authorised.
If your company is the first to market the product in a specific country, you will be responsible for the Safety Data Sheet compiled in the official language of the country.
And here, the emphasis is on the word responsibility…
Let’s say you want to put the product to market in Hungary. It is possible that your (foreign) partner provides a Hungarian Safety Data Sheet with the product (even if they are not obliged to do so), however, this should always be treated with reservations (typically these Safety Data Sheets are produced by software).
We advise you to ask for the “original” foreign language SDS in these cases, because if the authority/partner discovers any errors or inconsistencies in the document, it will be partly on the basis of this document that the deficiencies can be corrected. In any case, it is recommended to have these Safety Data Sheets professionally proofread before using them for registration, or forwarding to a partner.
If you only receive a foreign language SDS, you will need to have it translated. There are no restrictions on the translation, you can translate it by yourself or you can have it translated either by a translation agency or by an expert company. One thing to note about the translation of a Safety Data Sheet is that “translation” also involves checking the classifications, the legal references, the content and form and many other technical aspects. The responsibility is yours, consider your options and choose the best solution.
Resellers, therefore, no longer have this responsibility or task. It is the obligation of the supplier to provide a Safety Data Sheet in the official language of the Member State and in accordance with the legislation in force at the time. However, in this case, it is also important which documents you accept and subsequently forward to your partners. It is also a PR tool that can affect the image of your company in the eyes of your partners or cause disruption to the distribution of your product. When choosing a supply partner, price should not be the only criterion, the above-mentioned issues should also be taken into consideration.
In itself, the fact that our partner does not provide a Safety Data Sheet with the product does not mean that they have not acted in a lawful manner. There are many chemical products that do not require a Safety Data Sheet. Exemptions or certain facilitations are determined primarily on the basis of the use and hazard classification of the product.
In our experience, not having a Safety Data Sheet for a chemical product can be a source of problems in everyday practice. In such cases, we are constantly having to explain ourselves to our partners or to the authorities (proving that the product is not classified as hazardous, which is difficult to prove in the absence of an SDS). However, in these cases, we have a minimum obligation to provide information, and let us face it, the simplest and most acceptable way to provide information is to give or have a Safety Data Sheet.
We recommend that you request a Safety Data Sheet from the supplier even for products not subject to an SDS obligation and have it translated and adapted (if it is in a foreign language) in the same way as we have suggested for other products subject to an SDS obligation. If the supplier does not provide a Safety Data Sheet, either have an expert prepare the SDS or summarise the available data and information on the product in a document similar to the structure of the Safety Data Sheet. In the latter case, it is important to not define the data sheet as a “Safety Data Sheet”, as this will not allow for the document to be required to comply with the content and format requirements for Safety Data Sheets, but will allow for the transmission of basic and necessary information.
The Safety Data Sheet must be given to your customer at the time of the first delivery of the product. In case of multiple (continuous) deliveries, you only need to provide an SDS again if you have a newer version of the Safety Data Sheet available in the meantime.
In any case, the Safety Data Sheet must be handed over in a verifiable and documented way, as we need to be able to prove that we have handed over the SDS to the customer in the event of an official inspection.
It is important to understand that the relevant regulations require an “active” handover, not a “passive” availability. Once you understand the difference between the two approaches, you will understand why a Safety Data Sheet uploaded to a company website is not a valid handover.
Good practice for the handover of an SDS is to send it by email, or to hand it over when you receive shipping documents (e.g., a delivery note), or when you receive an invoice. Handover on the website will satisfy the requirements if registration on the website is required or if a “digital trail” is left that can be used to prove the handover at a later stage.
As is apparent from the above, the transfer of the SDS can be done electronically, on physical media or in printed form (but always free of charge).
If you are a reseller, your partner must have already labelled the products in in the local official language in accordance with the regulations in force (if not, do not take it over). In practice, however, in some cases the packaging may have been damaged, and with it the labelling as well, so you will have to relabel it (or send it back to your partner, as agreed). You cannot distribute the product with a faulty, damaged or missing label.
Please keep in mind that chemical safety legislation is constantly changing, so please check the consistency of the Safety Data Sheet and the label upon receipt of each item. In many cases, you may have received a newer version of the Safety Data Sheet, but the labelling had not been changed accordingly (or vice versa).
As the distributor responsible for placing the product on the market in your Member States), it will be your responsibility to ensure that the official local language label is in accordance with the Safety Data Sheet. It is possible that the foreign partner may already has sent the product with a multilingual label. In this case, you should check the wording (translation) and the conformity of the label to the Safety Data Sheet, as is the procedure for resellers.
We have the same professional reservations about foreign language labels produced abroad as we do about Safety Data Sheets produced by software.
Yes, distribution can be started, however, your tasks regarding chemical safety are not complete.
Product-related Safety Data Sheets, label drafts, and notifications may need to be reviewed or amended for a number of reasons.
The statute of limitations may be caused by changes in legislation, changes on the manufacturer’s “side” that may affect the composition, or even new information about the product that may justify changes in the Safety Data Sheet and, accordingly, in the labelling.
As previously indicated, you must submit any substantial changes made in the Safety Data Sheet to the authority via the PCN submission portal by updating your previous notification (if you are the duty holder).
In order to keep track of the changes, choose a supplier who is willing to keep you informed of the changes through active communication (the fact that they have updated the Safety Data Sheet on their website does not constitute providing information).
For the distribution of chemical products, it is essential that your company develops a strategy to ensure long-term compliance with chemical safety legislation.
REACH regulation affects all participants in the supply chain, including distributors.
Distributors have an important role, and therefore an obligation, in the flow of information between customers (end-users), manufacturers and importers (as the main data holders).
In practice, REACH information flow is an active intermediary function. The transmission and transfer of the Safety Data Sheet to customers serves this purpose (partly), however, the distributor may have more tasks in terms of their communication obligations.
First of all, cooperate with the inspection bodies, it is in the interest of both parties (you included).
The aspects of the on-site inspection will be determined by the “statuses” discussed earlier. In the end, a report on the results will be drawn up.