Pharmaceutical quality raw materials – everything you should know
Pharmaceutical quality raw materials is an advantage that manufacturers like to emphasize and should be proud of. Although it is not necessary for the e-liquids industry, some manufacturers want to surpass the quality standards. Therefore, many e-liquid manufacturers use pharmaceutical quality raw materials (like pure nicotine, PG/VG) in their production. In this article, we take a closer look at what you, as an e-liquid manufacturer or e-liquid brand owner should know about the quality of raw materials. Learn how to check if the product’s quality is as high as you expect.
We are happy to announce that our pure nicotine is now fully REACH registered, what does it mean?
REACH requires all companies manufacturing or importing chemical substances into the European Union in quantities of one tonne or more per year to register these substances with European Chemicals Agency (ECHA) in Helsinki. Sales of substances, which have not been pre-registered or registered, to the European market, is illegal.
REACH also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals.
To register, a manufacturer must collect and submit all data on the hazardous properties of substances manufactured or imported in quantities above 1 tonne per year. Submitted data is then evaluated by appropriate authorities. Substances of high concern such as carcinogens or mutagens will have to be authorised by ECHA, which ensures that risks from the use of such substances are either adequately controlled or justified.
Each substance that passes evaluation and authorisation is considered fully registered with REACH and is given a REACH Registration Number. PureNic 99+’s REACH Registration Number is displayed on Safety Data Sheet.
Welcome in our third and last article about REACH and CLP. We didn’t have the time and opportunity to talk about all the requirements coming from one of the biggest regulations in EU, but we will try to summarize the most important ones. Let’s do it on the example of our flagship product – PureNic 99+ pure nicotine.
When looking at nicotine description on our website, you will find the Safety Data Sheet (SDS) among other documents. SDS is required by REACH and it is supposed to be created for every hazardous substance. Supplier of a substance or mixture has to deliver an SDS to the entity that purchased said product. On our website, you will find the most recent version of the SDS, because this year a new CLP harmonized classification for nicotine has been published.
What is a harmonized classification? This is a classification that is mandatory in every EU country. Many substances have a standardized classification, that makes it easier to manage the risk associated with the substance.
According to Commission Regulation 2017/776 every manufacturer has to adjust their nicotine and nicotine products to new guidelines until 1st December 2018. We started doing it already – our SDS contains information compliant with the most recent classification.
New CLP classification will also impact nicotine e-liquids, which until now didn’t have to be classified as hazardous. New test results for nicotine proved that nicotine is considered more dangerous than before. The consequence of this change will be a new labelling system for nicotine and its products and also new requirements considering transport conditions for products that were free from CLP regulations until now. Regarding the packaging you can find elements that come from REACH – pictograms such as the exclamation mark, skull or dead fish; warning sign such as DANGER or WARNING and also Hazard Statements and Precautionary statements.
For very toxic substances or mixtures, you will also find a convex triangle that signals danger to the blind people. Of course, our nicotine is also pre-registered, as we mentioned in the first article. Our pre-registration number is 17-2120051720-67-0000. Right now we are half way to completing full-registration. This requires us to sign an agreement, pay the appropriate fee and then make the registration on REACH-IT website, using IUCLID tool. After completing full registration you will be able to find us on echa.europa.eu to confirm our status. The obligations associated with REACH are not over after the introduction and adherence to these requirements. You should follow up if there aren’t any further changes to the regulation, and I should mention, that there have already been 10 updates.
As you can see REACH is a comprehensive piece of legislation, and its exact exploration is a hard piece of work for many specialists. We are constantly trying to expand our knowledge. In the near future, you will be able to meet us at the Next Generation Nicotine Delivery 2017 in London, where we will talk more about this issue.
Thank you for your attention and we hope that we have managed to get you a little bit closer to the issue of REACH. Have a nice day.
Pure nicotine, nicotine bases and e-liquids manufacturers need to comply to REACH guidelines and regulations. What is REACH? Why is it so important to be REACH compliant?
REACH is one of the most important regulations of the European Parliament and of the Council that is already in force in the whole EU from 1 June 2007. It concerns chemical substances and affects many producers, importers and downstream users and also has an impact on our everyday life even if we don’t know about it.
For a start lets decode this mysterious name which is an acronym and comes from first letters of this phrase: Registration, Evaluation, Authorisation and Restriction of Chemicals. Decoding of this name immediately shows us what are the main goals and tasks of this (considered by many as difficult and complicated) regulations.
The first article of this law says that the purpose of this Regulation is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation.
As a general rule, REACH applies to all chemicals (with some exceptions) not just those used in industrial processes but also those used in our daily lives, such as cleaning agents or paints, as well as components of many products such as clothing or furniture. This is why the Regulation applies to most companies in the European Union.
As required by the regulation, companies must identify and control the risks associated with substances manufactured and marketed in the EU. They must demonstrate that the substance can be used safely and inform users how to decrease possible risk when handling the substance or its mixtures.
If risk management is not possible, the use of substances can be limited in many ways. In the longer term, the most dangerous substances should be replaced by less dangerous substitutes.
The REACH Regulation establishes procedures for collecting and evaluating the information on the properties of substances and the risks involved. Companies must register chemicals and to this end, they must cooperate with other companies registering the same substances.
Did you know that currently companies that want to produce or import for example nicotine in quantities more than 1 ton per year have to possess a special pre-registration number for this substance? And that by 1 June 2018 this pre-registration has to be transformed into full registration? Otherwise, you won’t be able to place your product on the market and you may face high fines or even jail depending on the country.
When it comes to our industry as a producer of e-liquids based on nicotine, we are pleased to inform that nicotine used by us is already pre-registered and our specialists are working on the full registration process of our pure nicotine to make it before next years deadline. There are much more duties and costs involved in the process if you are interested in more info simply visit www.echa.europa.eu run by the European Chemicals Agency or wait for our next article in which we will tell you more about CLP which is a major part of REACH.
This weekend you can meet us at EuroVape trade show in Madrid.
We will be exhibiting our products, both for manufacturers, distributors and individual customers. If you are looking for highest quality pure nicotine, nicotine bases, flavourings or custom-tailored solutions supplier, come and see us at booth C012 – on the main floor.
If you have any questions prior to the trade show or would like to arrange a meeting please contact our representative on firstname.lastname@example.org.
See you in Madrid!
The Vaper Expo 2017 is the biggest vape show in Europe taking place in NEC Birmingham on 26th – 28th May 2017.
Chemnovatic will be attending as an exhibitor for the first time, we are very excited and we would love to meet you.
If you would like to visit us, sample our nicotine bases or TPD ready e-liquids (including TPD e-liquids registered in England) or simply chat, we are waiting for you at Booth G30.
See you in Birmingham!
We have received a very unsettling e-mail from one of our customers who has apparently bought PureNic 99+ nicotine from a man posing as a distributor of Chemnovatic products in Russia. Not only was the product they received of very low quality, but it didn’t contain any nicotine. Obviously it was not a genuine Chemnovatic PureNic 99+ nicotine, but a counterfeit product. (more…)
We have received new certificates of analysis for our PureNic 99+ pure nicotine from the Eurofins lab. We are happy to announce that PureNic99+ is now officially over 100% pure.
PureNic 99+ pure nicotine Certificate of Analysis
For those wondering how is it possible for the nicotine to be measured above the 100% mark, here is a short explanation:
“Nicotine contains not less than 99.0 per cent and not more than the equivalent of 101.0 per cent of 3-[(2S)-1-methylpyrrolidin-2-yl]pyridine, calculated with reference to the anhydrous substance.”
Or if you would like to read it in full visit THIS link.
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