REACH i CLP

Discussion of selected legislation →

Polish legal acts →

UE legal acts →

We offer comprehensive services in the field of substance registration under the REACH Regulation

According to REACH, any substance produced or imported from outside the European Economic Area in quantities of more than 1 ton/year must be registered with the European Chemicals Agency. June 1, 2018 marked the last registration deadline under the regulation, by which substances produced or imported in the tonnage range of 1-100 tons/year had to be registered. At the moment, if you start manufacturing or importing substances above 1 ton/year, you must register the substance before placing it on the market. In this case, the first step is to submit an inquire dossier to ECHA, and then after obtaining the relevant information, contact the Lead Registrant to share data, prepare and submit the registration dossier. Our Team is active on behalf of registrants, offering comprehensive services to register substances, including:

• preparation and submission of inquiry documentation;
• contact with the Lead Registrant and the consortium to determine the terms of data sharing;
• preparation of registration documentation in the IUCLID program 6;
• submission of registration documentation to the REACH-IT portal.

We also offer services for updating registration documentation. The prerequisite for the service is the provision of the substance registration dossier in the form of a file generated by the IUCLID6 program (.i6z format).

We sincerely invite you to cooperate and contact us.

Almost every company that manufactures, imports or distributes chemicals is more than likely to deal sooner or later with substances or mixtures that require a safety data sheet.

If it turns out that the product you are about to put on the market poses a hazard, i.e. it is classified in accordance with the provisions of the CLP Regulation (1272/2008), among others, as:

• explosive, oxidizing, flammable;
• toxic, harmful, corrosive, irritant, sensitizer;
• carcinogenic, mutagenic or toxic to reproduction;
• posing a threat to the aquatic environment;

or

• when the substance meets the criteria for PBT (persistent, bioaccumulative and toxic) or vPvB (very persistent and very bioaccumulative) or is on the candidate list (substances of very high concern – SVHC),

you are under an obligation to provide the recipient with a properly drafted safety data sheet in the language of the country where the product is marketed.

in addition, when the product (mixture) does not meet the criteria for classification, but contains:

• a substance posing a risk to human health or the environment, in concentrations of at least 1 wt. % (or above the specific concentration limit) for non-gaseous mixtures, or at least 0.2 vol. (or above the specific concentration limit) in the case of non-gaseous mixtures, or at least 0.2 vol. in the case of mixtures that are in the form of a gas, or
• PBT, vPvB or SVHC substance in a concentration of at least 0.1% by weight for non-gaseous mixtures, or
• substance for which hygiene standards have been set in the European Union,

You are obliged to deliver the card to the recipient upon request.

This obligation results from Article 31 of REACH (1907/2006). The current format of the safety data sheet is set out in Commission Regulation (EU) No. 2020/878 of June 18, 2020. As of December 31, 2022, all safety data sheets provided must comply with the new format.

Development of the charter ≠ translation

The development of the charter is the responsibility of the supplier, i.e. the manufacturer, importer (outside the EU), downstream user or distributor who places the product on the market. Often, however, the safety data sheet prepared by the supplier does not meet all the requirements of Polish law, including those concerning the applicable hygiene standards. Literal translation of the original often leads to disregarding the law and lack of verification, such as the classification given by the manufacturer.

Remember: the safety data sheet is to enable the workplace to take the measures necessary to ensure safety and protect human health and the environment. On the basis of a properly drawn up safety data sheet, a label is developed to be placed on the product, which is intended to provide the consumer with comprehensive information about the potential hazards associated with the use of the substance or mixture.

That’s why it’s so important that both the card and the label are drafted correctly!

Initial evaluation of the supplied original cards is done free of charge.

In addition, we perform notifications of hazardous mixtures to the Bureau of Chemical Substances in Lodz (applies only to mixtures intended for industrial use) and notifications of hazardous substances to the CL List maintained by ECHA (applies to manufacturers or importers).

We also offer the service of reporting hazardous mixtures in accordance with Annex VIII to the CLP Regulation, as well as provide training on the provisions of the CLP Regulation and the principles of preparing safety data sheets.

So, if you want to be sure that the safety data sheet that you use in your enterprise and offer to your customers complies with the requirements of EU and Polish law in the field of chemicals, while the label has been prepared in the right way – and you think that our ancestors did wisely, inventing the social division of labor – use our services.

We offer services for the notification of hazardous mixtures in accordance with Annex VIII of Regulation 1272/2008 (CLP)

According to Article 45 and Annex VIII of the CLP Regulation, as of January 1, 2021, importers, downstream users (i.e., formulators of mixtures) and certain distributors are required to provide information on mixtures to designated authorities in a common harmonized EU format.

Notifiable information includes, but is not limited to:

• chemical composition of the hazardous mixture;
• identity, concentration ranges, and component classifications;
• classification and toxicological data of the hazardous mixture;
• product categories in accordance with the Harmonized European Product Categorization System (EuPCS).

In addition, the so-called UFI code – Unique Formula Identifier – must be placed on the product label.

For now, the above obligations apply to those marketing mixtures with consumer and professional uses in the EU. Mixtures for industrial use will be subject to the new regulations from January 1, 2024.

For mixtures notified according to national regulations (in Poland, this is notification through the ELDIOM system) before January 1, 2021. (mixtures for consumer and professional use) or before January 1, 2024 (mixtures for industrial use) there is a transition period until January 1, 2025.

We offer a service consisting of:

• assigning the mixture a UFI number;
• preparation of hazardous mixture notification documentation using the IUCLID6 program on the basis of the safety data sheet and additional information from the client;
• submission of the notification dossier through the ECHA Submission portal.

We sincerely invite you to cooperate and contact us.

Anna Bańkowska, PhD. Sc. – has several years of experience in consulting and training activities for Polish companies, co-author of analyses for entities of the Polish chemical industry on the implementation of the REACH regulation, co-author of opinions of legal acts commissioned by government bodies, experienced translator of technical documentation. Provides consulting and training on REACH and CLP.

Paulina Porębska-Sęktas, M. Sc. Eng. – has several years of experience in consulting and training activities for Polish companies, classification of chemical substances and mixtures in accordance with the CLP Regulation, co-author of analyses for Polish chemical industry entities on the implementation of REACH, deals with legislation on nanomaterials. Provides consulting, training and workshops on REACH, CLP, classification and safety data sheets.