REACH

Meeting all the requirements imposed by the REACH Regulation is not an easy task. It requires not only legal or chemical knowledge, but also involves the experience gained in practice. The fundamental question, which should be answered by any company facing the obligations resulting from the REACH Regulation is the scope, in which such company is subject to the provisions of this Regulation.

THETA Doradztwo Techniczne, wishing to help its clients to understand and fulfil their new obligations imposed by REACH, prepared a comprehensive offer for services covering this subject.

Analysis of your company’s needs regarding the specific obligations resulting from the REACH Regulation: „Verification Audit of the REACH obligations”.

Verification Audit is aimed at identification of obligations resulting from the REACH Regulation, and is completed with a written summary report. Verification Audit covers all the business elements considered by the REACH Regulation, from the point of view of a manufacturer, importer and downstream user, i.e., every company dealing with chemical products.

All Audits are conducted by qualified auditors, certified as the REACH Internal Auditors with certificates issued by the accreditation body RW TÜV NORD.

Conducting all registration procedures, included in the REACH Regulation:

• final registration of substances and intermediates – selection of the most economically justified way of registration.In scope of registration, we provide complete essential and logistics related services, inter alia, maintaining contact with European Chemicals Agency (ECHA), analysis and ordering of necessary tests for registered substances, representation in the Substance Information Exchange Forum (SIEF) and in consortium, representing company as a third party or as the only representative, development, preparation and submission of the complete registration dossier – also in IUCLID6 format.
• update of data for already registered substances.

Moreover, within the framework of obligations not related to registration, and resulting from the REACH Regulation, we provide:

• consulting and preparation of all documents for communication with suppliers, customers and European Chemicals Agency (ECHA), communication in the supply chain, preparation of suitable documents and applications, among others:
• support in interpretation of regulations concerning implementation of the REACH Regulation provisions, monitoring of changes in regulations, preparation of official letters and answering the legal enquiries;
• preparation of information for customers, concerning articles containing in their composition SVHC substances, and reporting to ECHA SVHC substances contained in articles;
• compilation of Safety Data Sheet in compliance with the REACH requirements and/ or suitable exposure scenario;
• preparation of information concerning hazards related to substances or mixtures not subject to the obligation of being accompanied by a safety data sheet;
• preparation of application concerning granting the authorisation for the use of substance in accordance with Annex XIV to the REACH Regulation;
• reporting to ECHA substances PPORD, i.e., substances manufactured or imported for the purpose of product and process oriented research and development, in accordance with Article 9 of the REACH Regulation;
• notifying of classification and labelling of chemical substances placed on the market;
• preparation of obligatory safety assessment and chemical safety report for so called unidentified uses (downstream users);
• and many more (do not hesitate to contact us for detailed information),
• review and evaluation of substances regarding the restrictions and prohibitions concerning placing them on the market in accordance with Annex XVII to the REACH Regulations and resulting regulations for specific groups of substances and chemical articles.

Moreover, it should be remembered, that in case of numerous chemical substances – both, on their own and in mixtures or articles, some additional regulations concerning restrictions during their import or export to and from European Union must be observed. The basic document here is the Regulation of the European Parliament and of the Council (EU) 649/2012 concerning the export and import of hazardous chemicals, implementing the Rotterdam Convention in the EU territory.

For over 2 years, that is since the United Kingdom formally notified the European Council of its intention to leave the European Union, the situation of companies on the British market is uncertain. Entrepreneurs from both United Kingdom and the EU are already experiencing the inconvenience associated with an unregulated leaving, as well as with what, regardless of the type of leaving scenario, may occur. Particularly since there is not much information on ways of resolving numerous legislative problems in the chemical products industry.

What may happen then?

The positive scenario – the so-called ”orderly BREXIT”

If the United Kingdom “cuts a deal” with the European Union regarding the agreement on the rules of exit, we can count on a soft scenario of separation of England and the European Union. Most importantly, though, we can count on the implementation of a transitional period, during which the existing rules of trade relations, including the principles of marketing and management of chemical substances, their mixtures and articles will be maintained. The United Kingdom will still be a part of a uniform, common market, so there will be no customs or additional regulations. In the United Kingdom, the same requirements for chemical substances and mixtures as before will continue to apply during this time, i.a. those regarding the REACH registration, certification, documentation, prohibitions and restrictions, notification of cosmetics and biocidal products.

This period will last until 31 December 2020. Naturally, there is no knowledge as to whether the UK will restrict its own regulations until then. The transitional period is to give the UK companies time to prepare strategies for further cooperation with the EU and its partners there, so that mutual exchange is as easy as possible.

Negative scenario – the hard BREXIT

In the absence of consent to the soft leaving, the United Kingdom will suddenly cease to be bound by the European Union law. Freedom of movement for persons, goods, capital and services will cease to apply in the mutual relations, which means, among others, that the border controls between the EU and the United Kingdom will return from that date. All permits obtained for the marketing of chemicals in the EU, registrations and certificates will cease to apply, as the United Kingdom will become a third country overnight, without any agreement with the EU. Anything that will get to the territory of EU from the United Kingdom will be treated as import to the EU and will require obtaining all documents.
Unfortunately, the likelihood of the occurrence of hard Brexit is very real, but even in the case of a soft option, the time remaining to adapt the regulations and resynchronize the UK market with the EU market is too short.

 

How to prepare?

Unfortunately, all the rationales show that it is probably only at the last minute when we will find out whether the United Kingdom will leave the European Union in a soft or hard way. Therefore, not to make one’s own activities dependent on the decisions of others and not to be forced to make decisions at the last moment, and even after some time, it is best to be ready for both scenarios.

Storage of the supplies for the first weeks after the final date of BREXIT is a good, but short-term solution. However, the key is to take preventive actions that will be effective from the very beginning of Brexit. One of the methods is to contact the EU advisors, who will help in transferring documentation, permits and certificates to the territory of EU, so that after Brexit the movement of goods can take place without legal obstacles and that the made registration, notifications and permitswill still be valid.

 

How can THETA help you?

THETA Doradztwo Techniczne has been operating on the market of the European Union for almost 20 years and is constantly focused on the European Union regulations related to the implementation of chemical products to the EU market. Our team consists of specialists who have knowledge of the EU laws enabling the legal marketing of them. Based on our experience and skills, we can offer a range of activities that will ensure free circulation of chemical products within the EU after the date of Brexit (some of the decisions should, however, be taken earlier, as after Brexit not all legally ways will be possible).

Representing British companies in the EU after BREXIT by the so-called sole representative

In accordance with the requirements of the Regulation 1907/2006/EC, all substances manufactured or imported in the European Union in quantities of at least 1 ton/year are subject to registration. Manufacturer and/or importer are in charge of the registration. In the case of companies from outside the EU, in order to legally place the chemical products on the EU market, it is necessary to designate the so-called sole representative for the company, who, according to Art. 8 of the REACH regulation, will register the substance and will be responsible for it.

To provide support for your company, THETA offers:

• assistance in the process of identifying substances that are subject to registration,
• registration of substances in accordance with the REACH regulation,
• assistance in communication with the European Chemicals Agency, the leading registrant, SIEF, or the consortium,
• development of the documentation required during the registration, in accordance with the REACH regulation,
• formal transfer of the function of the sole representative from another entity to THETA,
• consultancy regarding the EU regulations for a non-EU company and its clients.

Representing companies from outside the EU within the EU after BREXIT as the so-called sole representative (the companies that had sole representatives in the United Kingdom)

According to Art. 8 of the REACH Regulation, only the company which has its registered office in the EU can become a sole representative. Therefore, the sole representatives based in the UK after BREXIT must resign from this function and transfer it to another EU entity. Therefore, THETA proposes:

• taking over the role of the sole representative of a non-EU company,
• consultancy regarding the EU regulations for the company and its clients.

Support for companies in the process of transferring registration to another legal entity in accordance with the procedures of the European Chemicals Agency

According to the regulations, the registration of substances must be carried out by each producer and importer of chemical substances placed on the market in quantities of at least 1 ton/year. When a change in legal personality due to the acquisition of a company takes place, its absorption by another company or division into several smaller ones, it is possible to transfer the already completed registration to another legal entity. As a part of such transfer, THETA offers:

• technical change of the legal entity in the REACH IT system,
• assistance in communication with the European Chemicals Agency, the leading registrant, SIEF, or the consortium.