As 2019 drew to an end Tukes (the Finnish Safety and Chemicals Agency) issued a number or product recalls on tattoo and PMU inks. We found these alerts on their website, posted them and later they were taken up by the EU RAPEX system.
We wanted to find out what their process was for finding these inks and get a little insight into how they work and what the protocol is for dealing with reported or a possible unsafe tattoo product.
Senior Officer from Tukes, Jussi Ollikka was kind enough to answer some a few questions regarding the tests on tattoo and PMU inks as well as some more generic questions about how TUKES operates. You can find the email conversation below.
Is there a procedure for selecting the inks you test and are the tests completely random?
For the general process of selection we do use a risk based approach to narrow down our selection of the colors but the actual sampling is spot checks.
How long do these tests take from the point a request is made for a test to the receiving of results?
Few weeks but this is quite dependent on the laboratory and their workload.
Are there currently any systems in place for alerting manufacturers, tattooists and tattoo studios directly of recalled inks or is the TUKES website and RAPEX the primary means for alerts in Finland?
Unfortunately we do not have information on any other national systems apart from our national Tukes’ Julki-MAREK system. RAPEX (Safety Gate) and also ICSMS also used to deliver information of products that are non-compliant: https://ec.europa.eu/consumers/consumers_safety/safety_products/rapex/alerts/repository/content/pages/rapex/index_en.htm and https://webgate.ec.europa.eu/icsms/public/productSearch.jsp?locale=en
If TUKES is alerted that a person has had an adverse reaction to a tattoo or PMU ink is that grounds for a product recall to be made or are laboratory tests required before such recalls are announced?
There are a lot of reasons that might cause adverse effects to a consumer(e.g. poor hygiene during the tattooing process). We would take the case into consideration but not necessarily take further investigations. Case by case judgement is needed. Anyway we would guide the consumer to contact health care if problems arise.
Do you think the current testing of tattoo and PMU inks in Finland and the EU is adequate in terms of the amount of products tested?
If not, what would you like to see happen and how do you think this should be funded (by the EU, tattooists or manufacturers etc..?)
Depends on which this refers to. We have to keep in mind that the duty to place compliant products on the market is on the duty holders and they have to make sure and be sure that the inks are in accordance with the legal requirements. This can be achieved by example testing the products. The inks as well as many other products in the EU market are not subject to pre-approval process by the authorities and therefore testing done by the authorities is always gone be spot check-type of testing.
With the ECHA expected to release new legislation on limits and permitted chemicals in tattoo and PMU inks, is there any new procedures expected for ensuring tattooists adhere to only purchasing inks that follow this standard. ie, will inks that don’t or can’t meet these guidelines be immediately banned or will there be an amnesty period for suppliers and tattooists to restock their supplies?
Currently the new restriction set in REACH is under development so we do not have the final wordings on the restriction. Naturally the inks that are placed on the market need to obey the restriction requirements. Just as a side note that for the new REACH restriction those substances that are now included in ResAP are also being considered in the new restriction. Those substances in ResAP are already currently being enforced in many countries since they have been encompassed into national legislation.
Is there currently, or will there in the future be any legal actions put in place for tattooists, tattoo suppliers or manufacturers that fail to adhere to the ECHA legislation on tattoo inks?
Enforcement is dependent on national practices of each member state so the precise legal actions are dependent on national legislations. Each EU country is however obligated to enforce REACH. Tukes also enforces safety of consumer services from consumer safety perspective and this service safety enforcement covers also tattooing places in Finland. Other EU countries also have consumer service safety inspectors who enforce the safety related to these types of services.
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