Classification, Labelling &
Packaging (CLP) Review

The Classification, Labelling and Packaging (CLP) Regulation 1272 was introduced in 2008 to ensure there is a high level of protection of health and the environment in the EU.

One its main aims is to determine whether a substance / mixture displays properties that lead to a hazardous classification. When toxicological data meets the classification criteria, the hazards of a substance / mixture are identified by assigning a certain hazard class and category.

Once a substance or mixture is classified, the identified hazards must be communicated to other in the supply chain, including consumers. Hazard labelling allows the hazard classification, with labels and safety data sheets, to be communicated to the user of a substance or mixture, to alert them about the presence of a hazard and the need to manage the associated risks.

CLP sets detailed criteria for the labelling elements: pictograms, signal words and standard statements for hazard, prevention, response, storage and disposal, for every hazard class and category. It also sets general packaging standards to ensure the safe supply of hazardous substances and mixtures.

Who is CLP for?

Anyone involved in the manufacture, import, distribution or sale of e-liquids, flavours, bases, shots and short fills needs to adhere to CLP regulations.

Helping business comply with CLP and advertising standards

Labelling and packaging e-liquid and vaping products to the requirements of CLP and the Advertising Standards Authority (ASA) is a tricky exercise. With our expertise in regulatory compliance and in-depth experience in helping our clients in this field, let us take care of your products.

We will review your product’s labelling and packaging while you are in the design stage. This will help to get your products to regulatory standard the first time, ensuring you won’t suffer a loss due to product recalls or for legal implications.

Further information: https://echa.europa.eu/regulations/clp/understanding-clp

Work with scientists, work with ADACT

Companies around the world have trusted ADACT with their regulatory compliance.

  • Consult with a world renowned compliance agency who knows compliance and has an excellent understanding of the science behind it – not all compliance agencies are scientists and regulatory experts with this in-depth knowledge and expertise.
  • All our testing is completed in our own state of the art ISO 17025 accredited laboratory, providing results you can trust and rely on.
  • Choose an agency with proven results who is dedicated to your success. We have immense experience in providing compliance with over 1,500,000 TPD notifications since May 2016.

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Safety data sheets (SDS)

REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) Regulation EC No 1907/2006 Annex II, 2019 is a regulation of the EU designed to improve the protection of human health and the environment from the risks than can be posed from chemicals.

Under REACH Regulation EC No 1907/2006 Annex II, it is a legal requirement for electronic cigarette and vaping companies to provide a compliant safety sheet for all chemical mixtures sold – zero nicotine short fills and products that do contain nicotine, also require safety sheets.

What information is required on safety sheets to be REACH compliant?

Annex II is complex. In brief, it requires: identification of the mixture, hazard identification, composition of ingredients, first aid measures, firefighting measures, accidental release measures, handling and storage data, exposure controls, physical and chemical properties, stability and reactivity data, toxicological and ecological data, disposal considerations, transport details, regulatory information.

The aim of REACH is to protect human health, particularly children – ensure your sheets support this aim. Beware, some companies are cutting corners and producing low cost sheets from unqualified staff, which do not meet the new requirements and are not legal in the EU.

Produced by qualified, trained experts

Our staff have been fully trained and are qualified to produce REACH 2019 compliant safety sheets. We have the ability to produce sheets in any language for ease of compliance around the globe.

To produce a safety data sheet, a full formulation of a product is required. ADACT is well positioned to provide this service, especially if we have completed regulatory compliance on your products, because we have all the existing formulation data. Ideally, a safety sheet should be provided before, or at the time of first delivery of a substance or mixture. If new information on hazards or risk management measures becomes available at a later date, the SDS can be updated accordingly and without delay.

SDS for non-vape products

Due to our uniquely scientific background, we offer our SDS service to companies who have products outside of the electronic cigarette and vaping industry. Some examples of recent non-vape SDS sheets we’ve recently completed include: CBD products, cosmetics, candles and household chemical products.

Work with scientists, work with ADACT

Companies around the world have trusted ADACT with their regulatory compliance.

  • Consult with a world renowned compliance agency who knows compliance and has an excellent understanding of the science behind it – not all compliance agencies are scientists and regulatory experts with this in-depth knowledge and expertise.
  • All our testing is completed in our own state of the art ISO 17025 accredited laboratory, providing results you can trust and rely on.
  • Choose an agency with proven results who is dedicated to your success. We have immense experience in providing compliance with over 1,500,000 TPD notifications since May 2016.

Request your call back

Please fill in the form below and our team will get back to you as soon as possible within office hours





Book my support

Call or email ADACT using the buttons below to book your support

Pre-Market Tobacco
Product Application

On 10 May 2016, the American Food and Drug Administration (FDA) formalised its authority to regulate electronic cigarettes and vape pens under the Federal Food, Drug and Cosmetic Act, as amended under the Family Smoking Prevention and Tobacco Control Act.

Following the PMTA deadline of 9 September 2020, we announced ADACT had completed over 1,000 submissions on behalf of 20 major brands. Read more by pressing here…

Raising safety standards

Pre-Market Tobacco Product Application Marketing Order (or PMTA for short) was introduced to ensure vaping products are safe to consume and to raise standards in the American vaping industry to protect consumers. The new rules apply to companies wishing to sell existing or new electronic cigarettes and vaping products in the US. It now comes into force on 9 September 2020; previously 9 May 2020.

PMTA’s are issued by the FDA and permit tobacco products to be legally marketed in the US. To issue a PMTA, the FDA first evaluates a product based on a public health standard that considers the risks and benefits of the product to the population as a whole, for users and non-users.

COVID-19 Update

To give the worldwide electronic cigarette and vaping industry some time to breathe during the COVID-19 pandemic, the FDA requested US law makers extend the deadline. PMTA applications must now be completed no later than 9 September 2020.

Our PMTA partner

PMTA is one of the most challenging areas of regulatory compliance within the electronic cigarette and vaping industry. It is vital that you work with experienced scientists who have a proven track record, and who are globally respected and trusted in the industry such as ourselves. ADACT do not directly undertake PMTA work. We engage our US partner, Adact Medical US LLC who offer the same level of expertise and excellence for the US market.

Work with scientists, work with ADACT

Companies around the world have trusted ADACT with their regulatory compliance.

  • Consult with a world renowned compliance agency who knows compliance and has an excellent understanding of the science behind it – not all compliance agencies are scientists and regulatory experts with this in-depth knowledge and expertise.
  • All our testing is completed in our own state of the art ISO 17025 accredited laboratory, providing results you can trust and rely on.
  • Choose an agency with proven results who is dedicated to your success. We have immense experience in providing compliance with over 1,500,000 TPD notifications since May 2016.

Request your call back

Please fill in the form below and our team will get back to you as soon as possible within office hours





Poisons Centres:
Emergency Health Data

The Classification, Labelling and Packaging (CLP) Regulation 1272 was introduced in 2008 to ensure there is a high level of protection of health and the environment, and allow free movement of substances, mixtures and articles in the EU. Article 45 of the CLP Regulation requires companies placing hazardous mixtures on the market to provide information about their products.

In 2017, Annex VIII was added to the CLP Regulation. The new annex introduced one central poison centre – the ECHA (European Chemicals Agency) submission portal – to replace the existing individual country centres. Once a product is uploaded to the portal, the information is available throughout Europe.

How CLP affects vaping

Article 45 requires EU vaping companies (‘EU importers and downstream users’) to report their mixtures, ‘..placed on the market that are classified for human health..’.

What is required?

Full guidance is available on www.poisoncentres.echa.europa.eu/steps-for-industry

Principal elements include:
• provide the full chemical composition of the mixture – this means both the hazardous and non-hazardous components.
• label your product with a unique formula identifier (UFI) – the UFI allows poison centres to rapidly identify the product
• assign a product category according to the European Product Categorisation System (EuPCS).

Can I do this myself?

In short yes. It is worth noting that considerable technical expertise is required to compile a notification due to the technical information on the chemicals in each product.

How soon do I have to do this?

The deadline for submitting notifications is 1 January 2021.

How can ADACT help?

Due to the complexity of the process, many customers have asked us for help. We are able to register products with our trusted guarantee that it is done correctly and on time. As part of the registration process, we generate a Unique Formulation Identification (UFI) code. The codes must be clearly printed on corresponding product packaging to meet compliance requirements.

Poisons Centres and the UK

The current regulations for the UK require vaping companies to submit Safety Data Sheets (SDS) to the UK Poison Centre by email only – a digital service is planned for the future. Email sds@npis.org. Note: SDS must be REACH Regulation EC No 1907/1148 Annex11,2019 compliant.

Poisons Centres and Sweden

In addition to the standard ECHA Poisons Centres portal, Sweden now requires companies to notify The Public Heath Agency of Sweden via the EU Common Entry Gate (EUCG). Read more about this here.

Comply on time and help save lives: https://youtu.be/-7f88r6Dk0Y

Work with scientists, work with ADACT

Companies around the world have trusted ADACT with their regulatory compliance.

  • Consult with a world renowned compliance agency who knows compliance and has an excellent understanding of the science behind it – not all compliance agencies are scientists and regulatory experts with this in-depth knowledge and expertise.
  • All our testing is completed in our own state of the art ISO 17025 accredited laboratory, providing results you can trust and rely on.
  • Choose an agency with proven results who is dedicated to your success. We have immense experience in providing compliance with over 1,500,000 TPD notifications since May 2016.

Request your call back

Please fill in the form below and our team will get back to you as soon as possible within office hours





Book my support

Call or email ADACT using the buttons below to book your support