Who is responsible for a badly produced SDS?

The legal responsibility for an SDS lies with the company placing the product on the market, no matter if it is the manufacturer, importer or distributor. Even if the SDS was prepared by a third-party service provider, the company marketing the product remains fully accountable.

A non-compliant SDS can lead to regulatory penalties, product withdrawals or loss of trust with clients. Be sure that your SDS are authored or reviewed by qualified professionals familiar with the latest regulatory updates.

In which languages should I prepare my SDS?

An SDS must be provided in the official language(s) of each EU member State where the substance or mixture is sold. In practice, multilingual SDS versions are often necessary for companies operating across multiple EU markets.

It is important to assure the accuracy of translations. Simply translating the text may not be enough, as hazard phrases, exposure scenarios, and section formatting, must follow strict EU guidelines.

Pro tip: Always verify local language obligations and terminology, since some countries require additional national information.

How often should a SDS be updated, and why is it necessary?

An SDS mus be kept up to date to reflect the most recent information about the product’s hazards, composition and regulatory status.

Three cases require to update an SDS without delay. Firstly, when new information affecting hazard classification or risk management measures becomes available. Secondly, when a substance is subject to new regulatory restrictions or authorizations (eg. changes in REACHAnnex XVII or XIV). Finally when there is a change in supplier, formulation or composition, that affects safety information.

There is no fixed time interval defined to update the SDSs, but as a good practice, SDSs should be reviewed every 3 to 5 years to assure consistency with the latest CLP, REACH and ECHA updates.

Can I use AI to make SDS?

AI tools can reduce the workload to draft and structure parts of an SDS. However, no AI can replace a expert human review with experience in EU legislation.

An SDS is a legally binding document, and its accuracy depends on correct substance classification, exposure scenarios and regulatory interpretation. All of those subtleties require a qualified expert judgement.

If you are using AI-assisted tools, always ensure that a competent professional reviews and validates the content before distribution. Ultimately, the company placing the product in the market remains fully responsible for the SDS compliance.

Pro tip: AI can increase your productivity, specially for data management or multilingual formatting, but an expert shall always made the correct final chemical safety decisions.

What information should I include in my label?

A CLP/GHS-compliant label must clearly communicate the hazards of a substance or mixture thorough standardized elements:

1. Product identifiers: chemical name and/or trade name that clearly identifies the substance or mixture.
2. Supplier details:the name, full address, and telephone number.
3. Nominal quantity: the quantity of the substance or mixture on the package.
4. Hazard pictograms: standardized diamond-shaped symbols indicating the nature of the hazards
5. Signal word: Danger or Warning
6. Hazard statements (H-phrases): describing the nature and degree of the risks.
7. Precautionary statements( P-phrases): advising on safe handling, storage and disposal.
8. UFI number: for mixtures notified under the Poison Centres Regulation.

Like SDSs, the labels must be done in the official language of the country where the product is sold. In addition, labels must be visible, legible and durable on the packaging.

What is a UFI number and when must it appear on a label?

The Unique Formula Identifier (UFI) is a 16-character alphanumeric code that links a specific mixture to the information submitted to EU Poison Centers. It helps emergency responders quickly identify the exact composition of a product in case of accidental exposure.

A UFI must be printed on the label of mixtures classified for health or physical hazards. It is mandatory when a Poison Center Notification (PCN) has been submitted under the CLP regulation (Annex VIII).

If a product not hazardous, or it is used only in industrial sites, as an intermediary, where the label is not visible to consumers, the UFI is not necessary.

Pro tip: The UFI should be easy to locate. Usually is near the hazard pictograms or product identifiers, and it must always match the information in your PCN submission.

Can I reuse the CLP/GHS label for multiple EU countries?

Yes, but only if it meets all national language and legal requirements. The core hazard information (pictograms, singla words, H- and P-statements) is harmonized across the EU. However, labels must always be translated in the official language(s) of each country where the products are sold.

It is possible to design multilingual labels that include all required languages, provided the layout remains clear, readable and compliant. Take into account that some countries may also have specific national elements.

Pro tip. Always verify the language layout rules for each country before reusing a label. A single label version might not fit ever market!

When should a CLP/GHS label be updated?

A CLP/GHS label must be updated as soon as new relevant information becomes available.

In practice, you should revise the label when:

1. The composition of the product changes, affecting its hazard classification.
2. New data on physical, health, or environmental hazards become available.
3. EU updates: affecting regulations or harmonized classifications. For example, new entries on CLP Regulation, Annex VI, etc.
4. The UFI Number or supplier information changes

What is REACH registration?

The Regulation EC No 1907/2006 requires to ensure that all chemicals placed on the market are safe for human health and the environment. REACH registration is the process that assures this.

Any company that manufactures or imports a chemical substance into the EU in quantities of more than 1 tonne per year must submit a registration dossier to the European Chemicals Agency (ECHA). This dossier includes data of the properties, hazards, uses and risk management measures.

When the process is completed and accepted, the chemical can be legally marketed in EU.

Pro tip: REACH registration applies to substances, not mixtures. However, every component in the mixture must be already covered by a valid registration.

When is REACH registration required?

Is always required when a company manufactures or imports a chemical substance into the EU in quantities of 1 tonne or more per year.

Registration is required for:

1. Individual substances
2. Substances in mixtures, if the total amount of that component exceeds the 1 tonne limit.
3. Certain substances in articles, if they are intended to be released during normal use.

This obligation applies to manufacturers, importers, or Only representatives of non-EU suppliers.

Distributors and downstream users do not need to register substances but must be sure that they buy from compliant sources.

Pro tip: Check always if your substance is already registered by other companies and present a joint submission.

How much does REACH registration cost?

The cost of a REACH registration is quite variable and depends on three main factors:

1. The size of your company. ECHA fees are lower for SMEs and microentreprises
2. The tonnage band. Higher annual volumes require more data and testing, increasing costs.
3. The type of substances. Complex or hazardous substances often need additional studies or data-sharing fees.

How long does it take to register a chemical substance under REACH?

The time needed to complete a registration depends on the complexity of the substance, the availability of data, and whether or not you are joining an existing joint submission or preparing a new one from scratch.

The best case scenario, where the substance has been registered before and the data is accessible, the process can take only a few weeks to a few months.

However, if new studies are required or if you must generate your own data, the process might be relatively long, 6-18 months.

Also, take into account that ECHA must review your application, which might extent the overall timeline, specially for high tonnage or hazardous substances.

Pro tip: start planning your registration early. Hiring a consultant to coordinate the whole process might save you time in the long run!

What products are covered under BPR?

The Biocidal Products Regulation EU No 528/2012 applies to products that contain or generate chemical substances intended to control harmful organisms, such as bacteria, fungi, insects or rodents.

More specifically, BPR covers 22 product types, grouped in four main categories:

1. Disinfectants: for surfaces, water, air and human or animal hygiene.
2. Preservatives: to protect materials (paints, wood, plastics, etc.) from microbial damage.
3. Pest control products: this category includes insecticide, rodenticides and repellents.
4. Other speciality products: that do not fit in the other categories, such as nautical antifouling paints and embalming fluids.

Every biocidal product falling into those categories must contain approved active substances and obtain a national or EU-wide authorization.

Finally, products like cosmetics, detergents or medical devices, are regulated under different EU frameworks. Even if they contain antimicrobial ingredients, they do not fall under BPR.

What is the difference between active substance approval and product authorization?

BPR compliance has two main steps.

Firstly, Active Substance Approval happens at the EU-level. It checks the effectivity of the candidate substance as well as its safety for humans, animals an the environment. Once approved, it is listed in the Union list of approved active substances.

Secondly, Biocide Product Authorization can be national or EU-wide and it allows a final product (containing an approved active substance) to be commercialized. Once again, the product must demonstrate efficacy, safety and compliance with authorized uses.

To summarize, an active substance must be firstly approved at EU level. Then product authorization comes after for each market and type of formulation.

Pro tip: if you have several products with the same active substances, comparable uses and similar risk an efficacy profiles, you can group them under a single BPR authorization. This will minimize your compliance costs and fees.

Do cosmetics, detergents, or food-contact products fall on special authorizations?

Yes! Each of these product types is regulated under its own specific EU framework, separated from BPR or REACH.

Cosmetics must comply with Regulation (EC) No 1223/2009. You will need to compile a Product Information File (PIF), designate a responsible person, and notify to the CPNP the product before placing it into the market.

Detergents are covered by the Detergents Regulation (EC) No 648/2004. It requires to disclose all the ingredients, properly label the product and comply with biodegradability requirements.

Food-contact materials must comply with Regulation (EC) No 1935/2004, ensuring that those materials do not transfer harmful chemicals to the food.

In summary, while many products might involve chemicals, their authorization and compliance routes differ from biocides or general chemicals. Always check which regulation applies to your product before placing it to the market.

What are the timelines and costs for product-specific authorizations?

The timelines and costs vary wildly depending on the type of product, the regulatory route, and the data requirements.

Biocides, under BPR, are among the more complex. National authorizations can take 12-24 months, whereas UE authorizations may extend to 2-3 years. Regarding the costs, ECHA and national fees alone can range from a few thousands to tens of thousand of euros. Furthermore, you must take into account dossier preparation costs.

Cosmetics are relatively fast once all data is ready. They usually take only a few weeks. Costs are also lower, focused on safety assessments and PIF preparation.

Detergents and food-contact materials typically require documentation and testing, but not formal authorizations like the other groups. The timeline here strongly depends on testing and label validation. As a rule of thumb, we can consider 1-3 months.

Because each product and category has different levels of complexity, the best practice is to plan early and draft a good regulatory strategy where possible to save time and money.

What happens if my products are not compliant with EU regulations?

You should not take non-compliance is not to be taken lightly, as it can lead to serious legal and financial consequences. Authorities may require products to be withdrawn from the market, issue fines or suspend sales until compliance is achieved.

Ultimately, its not the administrative fines, but the reputation damage for your company leading to customer loss or even import bans.

The good news is that most issues can be prevented or corrected early with the right compliance partner. A regulatory consultant can help you assess gaps, update documentation, and communicate with authorities to help you navigate the complex regulatory landscape.

How can a consultant in chemical regulations help my business?

A well-defined strategy helps you map all regulatory obligations, optimize testing and data sharing, avoiding duplicated work across frameworks. From your point of view, it allows you to provide clear timeline and cost overview, so you can be compliant in a much more efficient way.

If you do not have the regulatory skills internally, a regulatory consultant can help you designing the optimal regulatory plan. Ideally, this plan should be drafted as soon as possible, even during product development. This proactive approach sees time, costs and avoids re-doing experiments, especially before launching or importing a product into the EU market.

What kind of documentation can YourChemLab prepare or review?

We are experts on EU compliance and we can support you with SDS authoring, CLP/GHS labelling, REACH registration, BPR authorizations and strategic consulting for your products. We can audit, prepare or update all regulatory documentation. We will make sure that your labels, safety data and submission dossiers are consistent across all EU markets.

How do I choose the right regulatory service provider?

Choosing the right regulatory partner is paramount to ensuring smooth, compliant market access.

Consider partners with proven expertise in your product type and regulatory pathway. Also, be sure that your partner has an advanced knowledge of EU and national regulations.

Besides the technical knowledge, prioritize a partner that offers clear communication and total transparency about timelines, projects, costs and responsibilities. In addition, flexibility is a nice feature to have in your collaborator to adapt the procedures to your company size and product portfolio.

Finally, take into account that strategic insight is not just planning annoying paperwork. A good compliance partner will help you plan ahead and integrate compliance into your business processes.

In summary, a regulatory partner should act as an extension of your team, helping you stay compliant, anticipate new obligations, and make informed decisions about your product portfolio strategy.