Supporting the chemical industry

ALSTER Vortrag: “Chemische Product Compliance (EU): Startpunkt das Produktetikett”
Mittwoch, 20. November 2024 14:00 – 15:30 CET

In diesem Workshop erwartet Sie eine interaktive Sitzung rund um das Thema Chemische Product Compliance erklärt aus der Perspektive des Produktetikettes.

Wir klären Fragen wie:

• Welche Piktogramme und Informationen müssen auf dem Etikett sein?
• Woher kommen die Informationen auf dem Etikett?
• Welche EU Regularien müssen allgemein bei der chemische Product Compliance beachtet werden?

Wir schauen Beispiele von Produktetiketten an und analysieren welche EU Regularien und Anforderungen im Bereich des Chemikalienrechts für die Produkte relevant sind.

Event organised by trade-e-bility GmbH
east Hotel Hamburg | Simon-von-Utrecht-Straße 31 | 20359 Hamburg

Registration: Product Compliance Workshop – Hamburg 2024

Chemical products meant for the general public are nowadays commonly advertised and/or sold via the Internet. While it is easy and convenient for consumers to search and buy products this way, the party announcing the products needs to comply with special requirements for chemicals, in addition to the requirements applying to the advertisement or trade for consumer products. Most important in this regard is Article 48, CLP. Please note that other requirements might apply, depending on your products, business model and the national legislation. In certain Member States products with specific hazards cannot be legally sold via the Internet.

Article 48, CLP: Advertisement

1. Any advertisement for a substance classified as hazardous shall mention the hazard classes or hazard categories concerned.
2. Any advertisement for a mixture classified as hazardous or covered by Article 25(6) which allows a member of the general public to conclude a contract for purchase without first having sight of the label shall mention the type or types of hazard indicated on the label.

While the content of advertisements for substances is well defined in paragraph 1, for mixtures paragraph 2 is blurry on what information needs to be provided. The term “type of hazard” is not further defined under CLP. ECHA Q&A 0273 is clarifying how the Member States authorities agreed to interpret the requirements:

“The type of hazard is best specified by providing the relevant hazard statements, including the supplemental hazard statements as referred to in CLP Article 25(6). It is also recommended that the hazard pictograms and signal word are mentioned, where appropriate, to alert the reader to a potential hazard.”

These interpretation and the recommendations agreed at EU level might be mandatory in some Member States. This is the case of Germany (see BAuA Q&A 374).

Who is checking?

It is to expect that due to the Corona situation, when most shops are closed and the inspectors need to reduce their contacts to a minimum, the inspectors focus on checking online shops, which can also be done from home office. In case of non-compliances found, depending on the Member State and the severity of the case, a penalty might be applied or only a warning and advise given. In any case, it is likely that the inspectors would block the offers until these are brought into compliance, which would have financial consequences.

Another consequence of non-compliant offers in online shops could be the receiving of notices with financial claims from parties monitoring the Internet for detecting any mistakes related to the advertisements or offers. Such notices are legal according to the consumer protection legislation and shouldn’t be ignored, even if the claims seem to be absurd or disproportionate. In such cases, it would be advisable to send back a formal objection, preferable prepared by a lawyer. An extreme example dating from April 2018 is the notice sent by Adolf Würth GmbH & Co. KG to a company distributing its products via eBay, which included claims in value of 7.500€ / infringement, plus 90.000€ notice costs. This case was described by Alexander Bräuer, specialised lawyer for the protection of industrial property rights, from the lawyer’s office Weiß & Partner in Esslingen.

Support

Big e-commerce platforms like Amazon and eBay adapted their offer formats to allow the display of the legally required information and established procedures to support the sellers to comply, but also to disable the offers, if flagged by the authorities as non-compliant. Independent shops have to take care of the compliance themselves. ALSTER can support you to design compliant websites and online shops.

According to Art 9(1)(i) of the Directive 2008/98/EC (Waste Framework Directive), starting 5 January 2021 articles containing SVHC above 01,%w/w need to be notified to the ECHA SCIP database before they are placed on the market. The SCIP notification needs to be done by all actors placing such articles on the market e.g. EU producers or assemblers, EU importers and EU distributors. For importers it is difficult to collect the necessary information.

Each supplier of the product is responsible for obtaining and keeping up to date the information on the presence of SVHC in its products. The data can be obtained by researching the literature or publically available sources, having branch specific knowledge, requesting information from its supplier of raw materials or products or by testing (last resort). The most common method in the industry is to include information requirements in the commercial contracts with the suppliers, combined with regular enquiries to the suppliers (e.g. annual).

For importers of finished products it is especially difficult to get this information because they have low or no knowledge on the materials / parts used and basically need to rely on the information provided by the non-EU manufacturer, which might understand the EU requirements or not.

Even when the importers know which SVHC are contained in which articles incorporated in their products, the problems for the SCIP notifications are not over. For example, part of the mandatory information that needs to be provided are the exact location of the articles in the product or the TARIC code for the article affected, which are often not made known by the manufacturer and not possible to be precisely determined by the importer.

The good news is that the EU authorities are aware of the situation and the European Commission is currently reconsidering the legal interpretation on the SCIP requirements for importers. ECHA will revise its Q&A 1609 when a new interpretation will be available.

Special case: Batteries

If batteries are incorporated into the products you import into the EEA market and your supplier didn’t inform you that they contain SVHC, it is highly advisable to address your supplier and explicitly ask about this information. Here there are three good reasons why you should do this:

1. It is very likely that batteries contain SVHC. A simple search on the Internet would reveal that Lithium batteries might contain 1,2-dimethoxyethane; ethylene glycol dimethyl ether (EGDME) (EC 203-794-9; CAS 110-71-4) or 1,3-propanesulton (CAS 1120-71-4)
2. SCIP database will be one source for inspectors / authorities to plan inspections and check products. Batteries are incorporated in many electronics and if not included in the notification of electronics, it might raise suspicions and trigger checks. In addition, batteries are legally uncomplicated and easy to check. There has already been a decision at EU level that batteries are regarded as articles and no discussions on the legal interpretation between inspectors and the industry is necessary (see page 70, ECHA Guidance on requirements for substances in articles).
3. Batteries will get more attention within EU in the coming years. The Batteries Directive is under review and will be significantly revised to allow all in all better control of batteries and to reduce their number in the waste stream (e.g. the ban of single use batteries is intended).

Support

ALSTER can help to prepare:
– strategies and tools for SCIP notifications
– enquiries to non-EU suppliers
– solutions to fill in data gaps
– SCIP submissions

Are your products labelled with one of the following pictograms and hazard statements and they originate or are sold from or in Germany, even if only in the accountancy books?

Then your company needs to implement ChemVerbotsV before it starts to trade.

ChemVerbotsV stands for the German Chemicals Restrictions Regulation. It requires, besides imposing national restrictions for chemicals, that chemicals of special concern (life threatening, serious health risks, flammable properties) are well controlled during their entire life-cycle, along their entire supply chain: the staff handing over such products is qualified, proper safety information is available to all actors in the supply chain and the transactions are well documented.

The requirements differ if the products are provided to consumers or professional users, being lighter for products supplied to professional users. For example, suppliers to consumers need a license and certified staff in each branch, while suppliers to professional users must only notify its activity to the authorities and it is enough to have staff trained by any certified expert (in-house or external). In both cases, the staff handling or being involved in the transactions needs to be 18 years old and reliable (not legally defined). Also the level of information collected from customers is the same, but the way it is recorded is different: for consumer products a physical register needs to be maintained, while for professional products any form of record keeping would be accepted.

ChemVerbotsV is not new, but till recently neglected by many because its requirements were conflicting with EU legal provisions (e.g. REACH Annex XVII and CLP). With its republication in 2017 this changed and its implementation and enforcement increased. It is also better structured and easier to read. However, its practical implementation is not easy. Just to name a few of the questions you might need to solve:

• What are the responsibilities of different branches and warehouses?
• How to check that customers use or resell the products legally?
• How to deal with exports from Germany?
• How to organise the needed expertise?
• How to use the IT systems in place (e.g. SAP) to keep appropriate records?
• Who is regarded as reliable?

Do you need help or a strategy to implement ChemVerbotsV? You are right by us.

Regulation (EU) 2020/878 updated REACH Annex II, which sets the requirements for the compilation of the Safety Data Sheets (SDS) within EEA. The main purpose of the update was to include in the SDS information on nanomaterials and on hazards related to endocrine disrupting properties, as well as to implement the requirements of the latest GHS version into the EU legislation. Newly prepared SDS have to comply with the regulation starting January 2021. SDS prepared before January 2021 have to be updated by 2023.

A summary of the main new data requirements is given below:

SECTION 1: Identification of the substance / mixture and of the company/undertaking
1.1 Product identifier: UFI for hazardous mixtures (mandatory only for unpacked goods)

SECTION 2: Hazards identification
2.3. Other hazards: Information on substances above 0,1% which are either

• identified as having endocrine disrupting properties according to criteria in Biocidal Products Regulation or in Plant Protection Products Regulation or
• placed on the Candidate List (SVHC) due to endocrine disrupting properties

SECTION 3: Composition/information on ingredients
3.1 Substances:
M-Factor
For substances with harmonised classification in Annex VI, CLP: Acute Toxicity Estimate (ATE)
For registered nanomaterials: particle characteristics

3.2 Mixtures:
Substances above 0,1% which are

• identified as having endocrine disrupting properties according to criteria in Biocidal Products Regulation or in Plant Protection Products Regulation
• placed on the Candidate List (SVHC) due to endocrine disrupting properties

Substances classified as skin sensitiser: from one tenth of the specific concentration limit
Substance related info: M-Factor, ATE, particle characteristics for nanoforms

SECTION 9: Physical and chemical properties
9.1. Information on basic physical and chemical properties: Additional explanations for various end points acc. GHS

SECTION 11: Toxicological information
11.2 Information on other hazards: For substances with endocrine disrupting properties, information on adverse health effects

SECTION 15: Regulatory information
15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture: Specific provisions e.g. conditions included in REACH authorisations

CLP excludes from its scope in vitro diagnostic medical devices (IVDs) in finished form (Article 1(5)(d)). Does this mean that a hazard label according to CLP doesn’t have to be prepared for a product registered as IVD? Not exactly. The sector legislation (Directive 98/79/EC, replaced by Regulation (EU) 2017/746 from May 2022), provides that CLP labelling requirements fully apply and only in special cases hazard label elements can be omitted.

Annex I, Chapter III, Section 20.1. (i)) of the IVD Regulation reads:
“The label shall bear all of the following particulars:

(i) In the case of devices containing a substance or a mixture which may be considered as being dangerous, taking account of the nature and quantity of its constituents and the form under which they are present, relevant hazard pictograms and labelling requirements of Regulation (EC) No 1272/2008 shall apply. Where there is insufficient space to put all the information on the device itself or on its label, the relevant hazard pictograms shall be put on the label and the other information required by Regulation (EC) No 1272/2008 shall be given in the instructions for use.”

Moreover, according to the CLP labelling requirements, the lack of space on a label cannot be justified with the need for translation. More languages than those required by the Member State(s) where the product is placed on the market can be used, provided that the same information appears in all languages used (CLP Article 17(2)) and that the label still fulfils the requirement of being easy to read (CLP Article 31). The ECHA Guidance on CLP further clarifies that the labelling exemptions for small size packaging are not allowed if a label becomes unreadable only because the supplier wishes to add more languages than required. (see Section 5.3., page 46).

The hazard information that needs to appear on the label of a hazardous substance or mixture is listed in CLP Article 17. In addition, the mandatory supplemental labelling information must be provided e.g. the REACH authorisation number, if an authorisation was granted.

Other CLP provisions than the labelling requirements, such as the notification to the Classification & Labelling inventory maintained by the European Chemicals Agency or the notification of hazardous mixture to the Poison Centers, do not apply to IVDs. However, please be aware that there are Member States that require the notification to Poison Centers also for IVDs under the national legislation.

If you need support in designing labels for your IVD products, ALSTER would be glad to advice you.