Regulation (EC) No. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, known as REACH Regulation¹, entered into force on 1 June 2007. As the title of the regulation indicates, the document governs the registration, evaluation, authorisation and restriction of chemicals. Among the objectives of this regulation is to ensure that manufacturers and importers of chemicals perform tests to determine the hazardous properties of the substances, and where substances with selected dangerous properties, posing a hazard to human health and/or the environment, are used, and to replace them step-by-step with less hazardous alternatives.

The main hazardous properties to which the authorisation and restriction obligations apply include (as regards human health) carcinogenicity, mutagenicity and reproductive toxicity in categories 1A and 1B. In the environmental domain, efforts to use less dangerous substances concern substances that are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative. In addition to chemical substances with such basic dangerous properties, the monitoring obligation and restrictions also apply to substances disturbing the endocrine system (endocrine disruptors) and substances that may adversely impact human health in other aspects, e.g., such as have highly sensitising effects if inhaled or aggressively affect specific human organs on repeated exposure.

An overview of such additional hazardous properties is included in Article 57 of REACH Regulation¹. Substances meeting such criteria are referred to as Substances of Very High Concern, abbreviated SVHC. Based on proposals from member states and subsequent public discussion, the European Commission decides on the addition of such substances to the candidate list of substances for inclusion in Annex XIV of the REACH Regulation¹, namely the “Candidate SVHC list”. This list is expanded periodically and contained 219 substances as of 8 July 2021.

The current version of the Candidate SVHC list can only be found on the ECHA (European Chemicals Agency) website: echa.europa.eu/cs/candidate-list-table, while it is not included in any legislative document.

The fact that a substance is added to the Candidate List (i.e. is proposed for inclusion in Annex XIV) imposes certain obligations on manufacturers, importers and downstream users, starting the day the substance is added to the list. Such obligations not only cover the substance on its own or its presence in mixtures, but also its presence in articles.

The main obligation is to transmit the information about the inclusion in the list along the supply chain, viz. via the safety data sheet (according to REACH Regulation¹ Article 31). This obligation also concerns substances present in mixtures at concentrations ≥ 0.1 wt.%.

Another obligation applies to the manufacturers and importers of articles that have the obligation according to Article 33 of the REACH Regulation ¹ to provide the recipient with information enabling the article to be safely used, including the name of the SVHC as a minimum. This obligation applies to articles containing the SVHC at a concentration ≥ 0.1 wt.%. Furthermore, Article 7 of the REACH Regulation¹ requires each manufacturer or importer of such articles to submit notification of any article containing a substance from the candidate list of SVHC to ECHA if the substance is present in those articles in quantities totalling over one tonne per producer or importer per year. This article notification must be performed by the manufacturer or importer within 6 months of the date the substance was added to the candidate list. This obligation is also enshrined in the Czech Chemical Act (Section 22 paragraph 7 of Act No. 350/2011 Coll.,²) enetering into force 1 January 2021.

Additional, and much more substantial, obligations arise on the inclusion of an SVHC in Annex XIV to the REACH Regulation¹ – i.e. LIST OF SUBSTANCES SUBJECT TO AUTHORISATION. If the European Commission includes a substance from the candidate list in Annex XIV to the REACH Regulation¹, the European Commission shall also set the “sunset date” – the date starting from which the substance must not be available in the market and must not be used unless permission is granted for specific use.

If the manufacturer or a downstream user wishes to make the substance available in the market or use it after the sunset date, they apply for an authorisation covering the use of the substance for a precisely specified purpose, and this application must be submitted no later than 18 months before the sunset date. The continuing use of the substance (use for which the application for authorisation was submitted) after the sunset date is possible until a decision concerning the application is issued. Once the decision has been issued, the substance can only be supplied and used in the specific supply chain based on the authorisation. Annex XIV is supplemented with additional candidate substances on an ongoing basis and contained 54 items as of

9 August 2021. The current list of substances included in Annex XIV to the REACH Regulation¹ can be found on the ECHA website: https://echa.europa.eu/cs/authorisation-list.

A list of authorisations and applications for authorisation for specific uses – the “REACH Authorisation Decisions”, can be found on: https://ec.europa.eu/docsroom/documents/46126.

Once the authorisation has been granted, the substance supplier must specify the number of the authorisation in the safety data sheet and on the label, and the downstream user must notify ECHA of the use of the substance within 3 months of the first supply, using the above number instead of the substance description. The use of the substance must comply with the conditions specified in the authorisation.

Selected information from the downstream user’s notification shall be transferred by ECHA to the manufacturer – authorisation holder to enable the manufacturer to use the information if they apply for a renewed authorisation.

Based on the obtained reports, ECHA adds information as to in which countries and in what amounts each substance included in Annex XIV may be used.

Among substances that must not be used without authorisation are materials containing hexavalent chromium, which find wide industrial use. This is illustrated by the fact that by the middle of this year, the European Commission had issued about 60 authorisations to use chromium(VI) oxide for functional chromium-plating and surface treatment of steel, tin-plated steel, aluminium, copper, cadmium and other metals and alloys for various industrial branches and also to formulate preparations for such uses. One of the authorisations even applied to the use of this material in the manufacture of propene.

The wide use of compounds with hexavalent chromium in the industry is also confirmed by statistical data extracted from the notifications submitted by downstream users, published on the ECHA website:

ECHA source: Downstream user notifications of REACH authorised uses.

The ECHA notification process requires certain knowledge of the IT tools, and as such ECHA developed graphic handbooks and videos for this purpose. No fees need to be paid for notification of an authorised use, but do not underestimate the size of the enterprise you enter when opening a REACH-IT account because ECHA reviews the data, particularly for entities with obligations on which fees are imposed. If, despite the existence of the supporting tools, you do not dare to start the notification process on your own, you can make use of the specific consultancy services we can get for you.

1. Regulation (EC) No. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
2. Czech Act No. 350/2011 Coll., on chemical substances and chemical mixtures

Author: Ing. Jiřina Taitlová

Since 1 January 2021, harmonised information on mixtures classified for health or for having hazardous physico-chemical properties according to Annex VIII to the CLP Regulation¹ must be submitted in PCN format (Poison Centres Notification Format). This new format is already mandatory for mixtures intended for consumer or professional use, while for mixtures that are solely intended for industrial use, this obligation has been postponed till 1 January 2024. Mixtures notified to the national register of chemical substances and devices before 1 January 2021 need not be declared in the new format until 2025 provided that no basic changes in the reported mixture occur till then.

Information can be submitted in the harmonised XML format, administered by the European Chemicals Agency (ECHA). The harmonised XML file can be set up by using the current IUCLID code or its online version, IUCLID cloud. This is not the first time ECHA uses such IT tools, you may have met with them, for instance, when submitting information according to the REACH² (registration), CLP¹ (substance classification notification) and BPR³ Regulations. The new PCN format in which information should be submitted to ECHA is primarily meant to unify the required data within the EU for mixtures that are put on the market, particularly identification of the mixture and of the entity responsible for putting it on the market, its composition, use(s), product categorisation according to the EuPCS, etc. This change also entails the obligation to report the unique formula identifier – UFI code, used by European poison centres to uniquely identify the mixture.

This obligation to notify the Poison Centre (European toxicology centre) applies, in particular, to the importers and downstream users. Since the submission of information in PCN format is one of the shared obligations within the supply chain, this obligation can also be indirectly passed on to the distributor.

The change in the declaration of mixtures within the European Union has also been transposed to the Czech national legislation, specifically by amending the Chemical Act⁴. It is noteworthy that this change also applies to mixtures that are also covered by other legislative acts, such as the Regulation on detergents⁵ and Regulation on biocidal products³, and to mixtures serving plant protection purposes⁶  – for this reason, the Ministry of Health has issued guidelines on the declaration of hazardous mixtures in accordance with Annex VIII to the CLP Regulation¹.

So, no exceptions can be used after 1 January 2025 and all mixtures that are put on the European market will have to be declared to the European Poison Centre in PCN format. The new mixture declaration is more tedious and time-consuming than the old declaration, and if you are seeking a reliable partner, contact us and we will be happy to provide this service for you. We cover the complete service portfolio and can be a reliable partner in other chemical legislation areas as well.

Authors: Ing. Aneta Nezmeškalová, Ing. Sabina Fraňková

1. Regulation (EC) No. 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP)
2. Regulation (EC) No. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
3. Regulation (EC) No. 528/2012 concerning the making available on the market and use of biocidal products (BPR).
4. Czech Act No. 350/2011 Coll., on chemical substances and chemical mixtures (Chemical Act)
5. Regulation No. 648/2004/EC on detergents
6. Regulation (EC) No. 1107/2009 concerning the placing of plant protection products on the market

A new nicotine product type has appeared in the Czech market: nicotine pouches, which are small casings containing a mixture of nicotine, flavouring ingredients and other substances, but no tobacco. The nicotine pouch is intended to be put in the mouth under the upper lip. Nicotine is released from the pouch and is absorbed buccally, that is, without the need to chew the material.

Until recently, nicotine pouches “floated in a vacuum” in the context of Czech legislation. This fact, among other things, posed a problem in regards to placing this product on the market in accordance with legislation. Nicotine pouches were not covered by the definition of a tobacco product because of the absence of tobacco in them (according to the previous wording of Act No. 110/1997 Coll.), nor could they be classed as food or medicinal products. So, the only remaining way out was to categorise nicotine pouches generally as chemical mixtures, or combinations of a mixture (filling on a carrier) and an article, which are subject to the obligations set out in the European REACH¹ and CLP² regulations.

The obligation to classify, label, pack, report in PCN format (to the poison centres) and develop safety data sheets, etc., according to the CLP² and REACH¹ regulations remains valid for the nicotine pouches, however, what is new is the inclusion of the nicotine pouches in Act No. 110/1997 Coll., on food and tobacco products³. This occurred  by amendment of the above act via Act No. 174/2021 Coll., of 13 April 2021. The parts of the act that concern nicotine pouches came into force on 12 May 2021.

By this amendment, Section 2 of Act No. 110/1997 Coll., ³ was extended with a point marked “za”, which defines a tobacco-free nicotine pouch as a tobacco-free product containing nicotine for oral use. No similar definition is included in the directly applicable European legislative document (i.e. Regulation (EC) No. 178/2002, laying down the general principles and requirements of food law⁴). Certain obligations applying to nicotine pouches basically copy the obligations applying to electronic cigarette refills, which are also  regarded as chemical mixtures (or combinations of a mixture and an article) from the legislative aspect. For instance, nicotine pouches must display information about contraindications, their addictive nature, toxicity, warning(s) for the risk groups and other mandatory information. A notification must additionally be sent to the Ministry of Health before importing any pouches or putting them on the market. The amendment, however, refers to an implementing regulation as regards specific conditions and requirements, but no such implementing document had not been issued so far. This concerns, in particular, requirements for product quality and for the scope of the information to be submitted.

The Czech amendment to the act got ahead of the European legislation as regards the nicotine pouch issue, because the European Union thus far does not regulate such products in any way . This situation, however, is likely to change soon: this change will probably consist in an amendment of Directive 2014/40/EU concerning the manufacture, presentation and sale of tobacco and related products (Tobacco Product Directive, TPD). This directive attempted to anticipate the ingenuity of the market, which offers new and new tobacco/nicotine products, by introducing the term “new tobacco products” but, as the report on the application of Directive 2014/40/EU remarks, “[…] the provisions are not specific to the unique properties of certain new products. Moreover, the directive does not fully cover some new tobacco-free products such as nicotine pouches for oral use.”⁵

In conclusion, we can await additional changes in legislation regarding tobacco-free nicotine pouches,  not only in the Czech Republic, but certainly in the European Union as well. We are monitoring the developments closely, and as such, if you are not sure or just wish to get insight into the current situation in this area, please do not hesitate to contact us, people who are qualified to help.

Authors: PhDr. Lucie Šerá, Ing. Sabina Fraňková

1. Regulation (EC) No. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
2. Regulation (EC) No. 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP)
3. Czech Act No. 110/1997 Coll., on foods and tobacco products
4. Regulation (EC) No. 178/2002 laying down the general principles and requirements of food law
5. Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the application of Directive 2014/40/EU concerning the manufacture, presentation and sale of tobacco and related products. [online]. Brussels, European Commission, 2021. [cit. 2021-7-20]. Available from: https://eur-lex.europa.eu/legal-content/CS/TXT/HTML/?uri=CELEX:52021DC0249&from=EN.

Electronic cigarettes and refills have been regulated by Czech Act No. 110/1997 Coll., on food and tobacco products since 2016. They are included in the text of the act either independently or within the tobacco product-related product group (together with herbal products intended for smoking).

The act enshrines the obligation to report information about the product and its market (volume, consumer groups, etc.) as well as to collect information on any adverse effects of such products on human health. The Act also regulates conditions for transboundary sale (i.e. sale via e-shops). Each manufacturer, importer, retailer and distributor must take measures to ensure that the products they handle meet the requirements of Czech Regulation No. 37/2017 Coll., on electronic cigarettes, replacement refills and herbal products intended for smoking. In addition to the requirements for the structure and details of the reports and registrations, the regulation also defines the labelling requirements, which are more detailed than the labelling requirements for tobacco products. In addition to the common elements such as the manufacturer, importer or distributor, product group name, weight and health warnings, the information must also include items such as the list of all ingredients present in the refill, nicotine content in the product/dose, warning that the product should be kept out of the reach of persons younger than 18 years, etc. In addition, the product must be accompanied by a leaflet containing additional information on the use and storage, contraindications, addictive nature and toxicity, etc.

What, however, is frequently forgotten is the fact that additional legislative documents exist, from which refills are not specifically exempt, specifically Regulation (EC) No. 1272/2008 (CLP Regulation) and Regulation (EC) No. 1907/2006 (REACH Regulation). In the meaning of those documents, the electronic cigarette refill liquid is a chemical mixture and hence, a safety data sheet must be compiled for it (for additional requirements see Article 31, and Annex II, of the REACH Regulation) and the product must be classified, labelled and packed in accordance with CLP Regulation Titles II, III and IV. This means that the label must include the warning symbol, the appropriate H-phrases and P-phrases, the signal word and additional information as may be appropriate (EUH phrases), as well as a list of the components due to which the mixture is categorised as hazardous (with certain exceptions). The refill volume must not exceed 10 ml, owing to which some exceptions from the CLP Regulation requirements apply. The H-phrases and P-phrases for certain hazard classes may be omitted, however, this does not apply to the “acutely toxic” classification, which is quite frequent for these products due to the nicotine content. Also, it is admissible to print the CLP label elements on the outer packaging only (e.g. on the box), but not on the bottle (immediate packaging).

So, the labelling of electronic cigarettes and refills is not governed by one, but by three legislative documents. If the products are included in your portfolio and you are not sure as to the labelling and wish to save time, contact us and we will gladly prepare the draft labels for you or review your labels or translate the labels so all the applicable legislative requirements are met. We cover the complete service portfolio for this product type and we can, of course, also be your reliable partner in other chemical legislation areas.

Author: PhDr. Lucie Šerá

We would like to invite you to our regular STN User meeting, this time organised as a webinar.

Date: 9 December 2020

Agenda:

9:30 – 10:00

What’s new on STN (in English)

Dr Basim Rahman, PhD, FIZ Karlsruhe, Senior STN regional marketing manager

10:00 – 10:30

Numeric Property Searching on STNext – new properties and new databases (in English)

Dr Ernst Aichinger, PhD, FIZ Karlsruhe, STN Trainer

10:45 – 11:30

Practical demonstration of searching in STN databases in the context of legislative obligations in the areas of chemistry, pharmacy, biocidal products and medical devices (in Czech)

Ing. Zuzana Asresahegnová, PhD, MEDISTYL s. r. o., literature search expert

11:40 – 12:00

Audits in practice and the quality system in literature monitoring (in Czech)

Mgr. Martin Krupička, MEDISTYL s. r. o., quality manager

Please send your registration to andrea.gavacova@medistyl.cz or use the registration form. Additional information will be sent to you after registration.

Registration closing date: 7 December 2020