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Perma Blend LUXE: France Update

Now Available: The NEW Perma Blend LUXE line

May 2024 Update: As regulations around the world advance, so do we.

Perma Blend LUXE has always met global safety standards. However, we recently learned that French regulations employ a stricter testing method with a lower threshold for a common microorganism. This differs from REACH, CTL and FDA requirements. To ensure compliance with France’s stringent standards, we've enhanced our manufacturing processes by working closely with the French authorities on this improvement to ensure future compliance.

Our new Perma Blend LUXE line will be available this summer. This relaunch ensures you have access to the most reliable and advanced inks available, highlighting our commitment to safety and quality.

The PMU industry continues to evolve, and we're committed to doing the same. This means you can trust our pigments to meet the highest safety standards, so you can focus on creating beautiful results with the highest quality inks on the market.

December 2023 Update:
What happened - We know everyone has seen different posts across social media and news platforms about Perma Blend, we want to address it personally with the Perma Blend family and community. Please note that this only applies to Perma Blend LUXE in France.In our industry it is standard to test microorganisms at less than 10 cfu. That is the standard used by CTL and the FDA. This is considered sterile and considered the gold standard for testing around the globe. This is the standard that Perma Blend has adopted.

All inks are pulled and tested frequently across the world by FDA and other regulatory agencies. Recently, the color Vivid Koral was selected by the French authorities for testing and tiny amounts of the common Bacillus microorganism were found to be present, which is commonly also found in water, air, and daily food products. All batches of our ink are tested for microorganisms by a third-party laboratory before they leave our facility and all inks pass. Samples of each batch are kept at Perma Blend, and after the French test results came to light, we retested and again received sterile results with less than 10 cfu.

Once the official documentation came through from the ANSM, we became aware that the French authorities test to a stricter standard with a different testing method. We spoke again with CTL. They test at the standard of less than 10 cfu, which again is the global standard. All CTL certificates indicate that our products are sterile, and all third-party analytical tests also indicate they pass for less than 10 cfu prior to leaving the facility. Perma Blend inks are proven safe.

What does this mean – We sought advice from a French medical expert to ensure the safety of our product. Since Perma Blend started manufacturing, we have not had one recorded event of adverse reactions to our ink. The medical expert reviewed records worldwide since 2000 and found no reports of infections from getting a tattoo associated with the Bacillus microorganism. The medical expert confirmed that the levels present in our ink are extremely low and there is no human health risk. A review of EU RAPEX from 2006-2010 found only recalls related to tattoo and permanent make up inks with a level of over 1,000 cfu.

This reassured us of the safety of all our inks.

Why did ANSM suspend sales of Perma Blend Luxe – Although the risk is considered very low, they are not able to test all batches and all colors and since we use the same sterilization process for all pigments, they have put the burden on us to provide further evidence, so they have suspended sales of Perma Blend on the French market in the meantime. While we feel this is hugely disproportionate, we take this issue very seriously so are complying with these requirements. We are working hard with the French Authorities to have ink that is compliant with the ANSM by February 2024.

Here are some of the questions we’ve had so far that we want to take the time to answer:

1. I’m not in France, how does this affect me?

a. You can continue to use your Perma Blend inks as usual. As noted, Perma Blend is safe and meets the requirements of global regulations. You can continue to use your stock if you are not in France.

2. How should I address my clients that I’ve already tattooed?

a. The clients on which you’ve used Perma Blend LUXE are safe and we find this Bacillus bacteria in food, water, and air in quantities far greater than 10 cfu. The decision by the ANSM in our opinion is disproportionate.

In closing, we know that many of you may be concerned, however the reality is we are confident based on the CTL and FDA testing protocols and the medical expert advice, that our inks are safe, you are safe, and your clients are safe.

We are learning, growing, and evolving every day and as regulations change, we evolve with them, just as we did with the REACH regulations. We at Perma Blend are committed to the artist and the industry and doing what’s right.