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.
