EU REACH Regulations Update

January 2022

EU REACH

What is EU REACH?

EU REACH is a regulation by the European Union (EU), adapted to improve the protection of human health and the environment from risks posed by chemicals.

EU REACH applies to all chemical substances; not only those used in industrial processes but also in our day-to-day lives, for example in cleaning products, paints, as well as articles such as clothes, furniture, cosmetics, and colors used in permanent makeup (PMU) and body tattoo.

What is the impact of EU REACH?

Effective January 4, 2022, the European Union (EU) will restrict the use of certain chemicals in tattoo inks and permanent makeup (PMU). The EU restriction aims to prevent the use of specific chemicals in tattoo inks and PMU that are known to have specific hazardous properties which make it more likely that someone might experience harmful effects. The restriction covers, for example: chemicals that cause cancer or genetic mutations and chemicals that are toxic to reproduction as well as skin sensitisers and irritants.

The aim is not to ban tattooing but to make the ingredients and colours used in tattoos and permanent makeup safer for use. The authorities examined the health risks of these chemicals and investigated the availability of safer alternatives.

Therefore, many colors that PMU and tattoo artists use will no longer be available in the EU for ink formulation, use and distribution.


Yes, there are many chemicals currently found in inks, pigments and ingredients such as certain preservatives, alcohols and derivatives are to be banned under this new legislation from January 4th, 2022 in the EU. Due to the EU REACH restrictions, a large part of pigments currently offered by Perma Blend including artist signature series may no longer be sold, bought, used and stored from January 4th, 2022 in the EU.

With regards to Pigment Blue 15 and Pigment Green 7, there is a transitional period before the ban starting from January 4th, 2023. This will allow ink formulators to find approved alternatives while ensuring the availability of green and blue inks in the meantime.

TINA DAVIES PROFESSIONAL X PERMA BLEND

 
What are Perma Blend and Tina Davies doing to be compliant with EU REACH?

With over 50 years of experience in the tattoo industry, Perma Blend has a proven passion for making premier products manufactured with the safest, cleanest and highest quality ingredients for the benefit of artists around the world.

As part of their constant quest for promoting excellence and safety in the industry, Perma Blend is committed to ensuring that their products meets  all new EU requirements per regulations established by EU REACH.

Perma Blend has developed a new line of inks called  ”LUXE” that will comply with the new standards to meet EU REACH regulations for the affected markets. This is a completely NEW line of Perma Blend colors across the spectrum of the most sought-after shades used by the world’s most in-demand artists.

Tina Davies Professional pigments are manufactured by Perma Blend. Our company will be working closely with Perma Blend in formulating and testing EU REACH compliant pigments and sending communication to our customers and partners to keep them informed and updated. We are committed to being proactive and as transparent as possible for the continued success of our customers and partners around the world.

The Tina Davies LUXE I ❤️ INK eyebrow and lip pigment collections will resemble the current line for the affected markets in order to provide artists with the outcome they are used to with EU-compliant alternatives that are authorized for use.

Perma Blend  will begin shipping Perma Blend LUXE products  to their European distributors  for worldwide distribution in early 2022. Once Tina Davies Professional receives the LUXE I ❤️ Ink products from Perma Blend in early 2022, all existing Tina Davies Professional Partners will receive communication regarding the new LUXE pigment products along with further instructions on how you can purchase these new products using your partner discounts.

Perma Blend will continually be adding to the line during the year and we will be providing our partners with updates accordingly.
 

EU REACH — FAQs

How does EU REACH impact artists around the world?

On a usage and resale level, the change in EU Regulation only impacts the EU market. This upcoming change will not impact artists in the USA and Canada or resellers distributing to customers located in the USA and Canada or anywhere else in the world, however it is likely that changes will come for the UK in the near future.

The Tina Davies LUXE I ❤️ INK pigments will be distributed in the EU market. Artists in the US, Canada and outside of the EU can continue to purchase the original color formulations.

Outside of the EU and UK market, there is no mention of any upcoming changes as of yet. Customers from the US, Canada and other countries can continue to purchase Perma Blend pigments as is. If regulation changes were to happen, Perma Blend will be given a proper transition period in order to apply the necessary changes to all affected pigment lines.

What will be required under EU REACH?

Under this new legislation, every produced batch of every single colour will need to be tested and documented. These tests will show if certain readings are within the limits such as for heavy metals and other ingredients.
The tests will have to be carried out by approved laboratories and if passed the documentation needs to be signed by the manufacturer and supplied to the authorities.

This means that even if a certain pigment is not banned but the manufacturing process is not “clean” enough, the product will not be allowed on the market under the EU REACH legislation.

Under EU REACH, another requirement is a standardization of the labelling of packaging of inks and pigments. This is required to ensure restrictions are correctly implemented. Hence, mixtures will have to mention this type of use on their labels together with a list of ingredients and relevant safety statements.

Will the banned ingredients change color or look bad later?

No, this change doesn’t affect the current Perma Blend pigments in the market which have consistently provided long-lasting, consistent results.

When do I need to stop using Perma Blend or Tina Davies I ❤️ INK pigments?

• If you are in one of the affected countries in the EU, you are to stop using the impacted pigment after January 4th, 2022.
• If you are outside of the EU, you may CONTINUE to use all of your Perma Blend pigments.
• No decisions have been made for the UK but we are expecting a change in restrictions in the near future.

Do I need to inform my clients of using compliant products?

• You are expected to ensure pigments/inks used meet the requirements that are becoming a law if you are in the EU.
• As a PMU artist, it is important before any type of procedure to ensure that non-compliant inks are not used in your PMU procedures as this could directly affect your business, reputation and client’s trust. An artist should be able to provide information — marked on the packaging or included in the instructions for use — to the person undergoing the procedure.

What shall I do with the pigments that I have? How do I know that the pigment line I am using is compliant with EU/UK REACH?

• Ensure that you are only buying pigments from reputable manufacturers which can supply you with the documentation (for example, Material Safety Data Sheets (MSDS) and reports of safety testing by trusted laboratories) needed to prove their safety.
• Look out for this statement present on the label: “Mixture for use in tattoos or permanent makeup”. This is one way of ensuring your pigments are compliant.
• If you decide to stock up on pigments before January 4th, 2022, ensure they are already compliant, otherwise you will not be allowed to use them after January 4th, 2022.

How do I know that the ingredient used in the pigment line is banned by EU REACH?

• Look for the ingredient lists on the packing and/or MSDS.
• Each color ingredient is usually identified by a CI number. For example, you can find the color “Yellow 14” as “CI-21095” in the ingredients list of your pigment.
• A simple Google search will tell you if the pigment is banned or restricted under EU/UK REACH.

If you are in doubt, please communicate with our Customer Success team at support@tinadavies.com and we will provide you with other paperwork such as lab test results to prove they have been tested and adhere to the legislation.


Does Tina Davies I ❤️ INK pigments contain ingredients banned by EU REACH?

EU REACH has banned/restricted pigments including the use of isopropyl alcohol, Yellow 14, Red 269 and Blue 15. In short, all of the color pigments from the Tina Davies I ❤️ INK collections are impacted by EU REACH restrictions.

Yellow 14:

• Brows: Ash Brown, Grey, Blonde, Medium Brown, Dark Brown, Bold Brown, Ebony, Sunset, Toffee and Autumn.
• Lips: Pink Rose, Dusty Pink, Peach, Orange Coral and Flame.

Red 269:

• Brows: Medium Brown, Bold Brown, Sunset, Toffee and Autumn.
• Lips: Wine, Pink Rose, Dusty Pink, Nude, Cinnamon, Soft Red, Pink Coral, Perfect Pink, Peach, Orange Coral and Flame.

Blue 15:

• Lips: Magenta, Wine, Pink Rose and Dusty Pink.

 
Tina Davies I ❤️ INK MSDS
https://www.dropbox.com/sh/vrtv0z6hd7s8d32/AABzY_jKVYNHRvi2i6ml_1eYa?dl=0

Additional EU FAQs (Jan 25, 2022)

Are we allowed to use and sell TDP and PB pigments worldwide?

Tina Davies Professional and Perma Blend pigments can still be used and sold worldwide EXCEPT for countries in the EU.

What is Tina Davies Professional & Perma Blend doing to ensure that the pigments are compliant?

Perma Blend has formulated an EU ingredient compliant pigment line called LUXE which is currently available now. The roll out for Tina Davies I ❤️INK brow and lip pigments is currently being formulated and tested and will also be available in 2022.

While we are waiting for the Tina Davies’ LUXE Collection to launch, what should we use in the meantime?

You can use the Perma Blend LUXE collection which is already released. Please go to www.permablend.com for more information.

If I am outside of the EU, can I continue to use and train with Tina Davies Professional pigments?

Absolutely! If you are located anywhere in the world outside of the EU region, you are more than welcome to continue using our Tina Davies Professional pigments.

UK REACH FAQs

What is UK REACH?

UK REACH is the UK version of the European EU REACH regulation on the Registration, Evaluation and Authorisation of Chemicals in Europe. In other words, it is your key to the UK Chemicals market. It is implemented by the UK Health and Safety Executive (HSE).

What is changing with UK REACH?

Despite the free-trade agreement, one of the biggest changes is the UK’s own chemicals legislation, namely UK REACH. This is a copy of EU REACH, and most of the legal regulations are identical. Amendments and non-completed procedures (e.g. authorisations) will not be automatically transferred to UK REACH from January 4th, 2022.

I am in the UK, will I be impacted by the change of regulation from EU REACH?

UK REACH is part of the UK's chemicals regulatory regime. If you sell or distribute chemicals like pigments in the UK and the EU, you'll need to follow both UK REACH and EU REACH rules. UK REACH maintains EU REACH’s aims and principles. EU REACH places the burden of proof on companies. Companies are required to identify and manage the risks present by substances they manufacture and market in the UK/GB. They must be able to demonstrate how the substance can be used safely and they must communicate the risk management measures to the users.

I am in the UK, what are the recommendations of UK REACH regarding pigment distribution?

Regarding other regulatory processes under UK REACH and UK CLP, HSE has confirmed they are currently working on two restrictions for lead shots and tattoo inks, analogous to restrictions adopted in the EU recently but not forming part of retained UK law. As of now, a decision has not been made by HSE. HSE is still examining the evidence presented in the restriction dossier prepared by ECHA along with other available information on certain harmful chemicals used in tattoo inks and PMU. 

Are we allowed to use and sell TDP and PB pigments in the UK?

Yes. Tina Davies Professional and Perma Blend pigments can still be used in the UK at this time.

REFERENCES

Official EU REACH REGULATION
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R2081&from=EN

HSE UK REACH
https://consultations.hse.gov.uk/crd-reach/restriction-proposals-002/

ECHA Proposal
https://echa.europa.eu/documents/10162/ef28addd-cdb7-aedb-0db9-167b00d3b81f

ECHA ANNEX XV RESTRICTION REPORT
https://echa.europa.eu/documents/10162/6f739150-39db-7e2c-d07d-caf8fb81d153

List of REACH Annexes
https://www.cia.org.uk/Portals/4/Documents/FAQ/REACHAnnexesv2Aug12.pdf?ver=2017-05-09-113934-160#:~:text=ANNEX%20XV%3A%20Dossiers%20%E2%80%93%20general%20principles,a%20substance%20within%20the%20Community

BFR Risk Assessment for Pigment Blue 15:3 and Pigment Green 7
https://www.bfr.bund.de/cm/349/tattoo-inks-risk-assessment-for-pigment-blue-15-3-and-pigment-green-7.pdf
https://permablend.com/pages/luxe

Tina Davies Professional MSDS
https://www.dropbox.com/sh/vrtv0z6hd7s8d32/AABzY_jKVYNHRvi2i6ml_1eYa?dl=0

Perma Blend MSDS
https://www.dropbox.com/sh/7r6iv60on2apqet/AACeHKunN6nJSXbvdYRlGIc3a?dl=0