Regulation (2012:503) Of Tattoo Colors

Original Language Title: Förordning (2012:503) om tatueringsfärger

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Read the untranslated law here: http://rkrattsbaser.gov.se/sfst?bet=2012:503

section 1 of this regulation are notified



1. pursuant to chapter 14. paragraph 4 the environmental code in question

If paragraph 3 and section 9 1 and 2,



2. on the basis of Chapter 14. section 12 of the environmental code in respect of sections 4 and 5

and 9 section 3,



3. pursuant to chapter 14. 19 § 1 the Environment Act in terms of sections 6 and 7

and section 9 (4) and (5),



4. pursuant to chapter 14. 19 § 2 Environment Act in respect of section 8, and



5. Moreover, pursuant to Chapter 8. section 7 of the Constitution.



Definitions



paragraph 2 of this regulation,



tattoo color: a product composed of dyes and

excipients and is intended to be injected into the skin tattoo

or permanent makeup, and



sterile: in the absence of living organisms and viruses.



Otherwise, words and expressions in this regulation the same meaning

as in chapter 14. the environmental code.



The introduction, the marketing and use



3 § tattoo color, professionally be introduced to Sweden,

be marketed or injected into the skin only if the color



1. do not have carcinogenic, mutagenic, toxic to reproduction or

other characteristics that make it at normal or reasonably

foreseeable use may be harmful to human health or the environment,

and



2. is sterile.



Product register



section 4 of the Agency shall keep a register of products

tattoo colors professionally manufactured in or imported into

to Sweden.



5 § The professional manufacture a tattooing ink or for

in such color to Sweden shall notify the

The MPA for registration in the product tables

referred to in paragraph 4. The notifier shall submit the information necessary for the

the registration. If the data is changed, the notifier shall inform the

The FDA about this.



Registration and notification of change shall be made in accordance with

rules that the FDA has notified pursuant to § 9

3.



Labelling and product information



section 6 of The professional marketing tattooing ink shall ensure

to its container and the outer packaging bear

information about the precautions that should be taken at

use and the information is otherwise required to protect

to human health and the environment. The information shall be provided in

easily legible and visible lettering.



section 7 of The professional injects tattooing ink in the skin to

inform the injected about tattoo color

content and properties.



section 8 of The professional manufacture, to Sweden or

marketing a tattooing ink shall immediately inform the

The MPA if it comes forward with new information about

tattoo color in question may have carcinogenic, mutagenic or

reproductive toxicity.



Authorization



§ 9 the FDA may provide for



1. concentrations of chemical substances and the prohibition of

chemical substances needed to tattoo colors

meet the requirement in section 3 1,



2. the requirement of sterility under paragraph 2,



3. registration and registration and disclosure obligations under

section 5,



4. labelling and product information under section 6,



5. the information referred to in section 7, and



6. the information to be included in a notification under

section 8.



Supervision



section 10 of the Regulations on supervision, see chapter 26. the environmental code and the

environmental protection Regulation (2011:13).



Fees



section 11 of the regulations on fees can be found in Chapter 27. the environmental code and the

Ordinance (1998:940) if the fees for the examination and supervision

According to the environmental code.



Responsibility



section 12 of the regulations on penalties and forfeiture due

infringements of this regulation or the regulations

issued pursuant to the regulation can be found in chapter 29. the environmental code.