Originating Department: Miljö- och energidepartementet
Responsible Department: Kommerskollegium
Received: 2017-06-30 00:00:00
Country: Sweden
Category: PHARMACEUTICAL AND COSMETICS
Draft Ordinance amending the Chemicals Products (Handling, Import and Export Prohibitions) Ordinance (1998:944)
Notification No.: 2017-0284-S
1. ------IND- 2017 0284 S-- EN- ------ 20170710 --- --- PROJET
1. ------IND- 2017 0284 S-- EN- ------ 20190508 --- --- FINAL
DRAFT
Swedish Code of Statutes
Annex 1 to the Government Offices decision
of 29 June 2017, § 164 (Ref. No M2017/01733/R)
Ordinance amending the Chemicals Products (Handling, Import and Export Prohibitions) Ordinance (1998:944);
Swedish Code of Statutes Logo added during processing
issued on 01 February 2018.
Ordinance
amending the Chemicals Products (Handling, Import and Export Prohibitions) Ordinance (1998:944);
With regard to the Chemical Products (Handling, Import and Export Prohibitions) Ordinance (1998:944), the Government lays down firstly that §§ 1 and 5 shall read as set out below, and, secondly, that the following four new paragraphs set out below – §§ 1a and § 4 (including the preceding subheading), §§ 4–4 b – are inserted into the ordinance.
issued on Click here to enter date.
§ 1 This Ordinance contains specific provisions on the prohibition or other restrictions on the management of
With regard to the Chemicals Products (Handling, Import and Export Prohibitions) Ordinance (1998:944), the Government hereby lays down that:
Two-component epoxy containing bisphenol A or bisphenol A diglycidyl ether,
§ 1 shall read as set out below, and
cadmium,
the three new paragraphs set out below – § 4 (including the preceding subheading), 4a and 4b – are inserted into the ordinance.
microplastics in cosmetic products,
§ 1 This ordinance contains special provisions concerning the ban or other restrictions on the handling of
chlorinated solvents,
1. two-component epoxy containing bisphenol A or bisphenol A diglycidyl ether,
mercury,
2. cadmium,
cadmium and mercury in batteries,
3. microplastics in cosmetic products,
heavy metals in packaging,
4. chlorinated solvents,
ammunition which contains lead,
5. mercury,
detergents containing phosphates, and
6. cadmium and mercury in batteries,
certain other chemical products and goods that are hazardous to health or to the environment.
7. heavy metals in packaging,
This Ordinance does not apply to chemical products and biotechnical organisms governed by the Food Act (2006:804), the Act (2006:805) on feed and animal by-products or the Medicinal Products Act (2015:315).
8. ammunition containing lead,
§ 1 a This Ordinance is issued by virtue of
9. detergents containing phosphates, and
Chapter 14, § 8 of the Environmental Code with regard to §§ 2–3, 5–11, 11 c–14 and 14 b–20 a,
10. certain other chemical products and goods that are hazardous to health or to the environment.
Chapter 15, § 40 of the Environmental Code with regard to § 4 a,
This ordinance is issued by virtue of Chapter 14, § 8 of the Environmental Code with regard to §§ 2–3, 5–11, 11 c–14 and 14 b–20 a, by virtue of Chapter 15, § 13 of the Environmental Code with regard to § 4 a, and otherwise by virtue of Chapter 8, § 7 of the Instrument of Government.
Chapter 8, § 11 of the Instrument of Government with regard to § 21, and
This ordinance does not apply to chemical products and biotechnical organisms governed by the Food Act (2006:804), the Act (2006:805) on feed and animal by-products or the Medicinal Products Act (2015:315).
Chapter 8, § 7 of the Instrument of Government with regard to other provisions.
Microplastics in cosmetic products
§ 4 For the purposes of §§ 4 a and 4 b
§ 4 In this paragraph and in §§ 4 a and 4 b the term cosmetic product means: a cosmetic product within the meaning of Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products,
cosmetic product: a cosmetic product within the meaning of Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products,
plastic: a polymer within the meaning of Article 3(5) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, to which additives or other substances may have been added,
microplastics: solid plastic particles that are smaller than 5 mm and insoluble in water,
plastic: a polymer within the meaning of Article 3(5) of the Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 Decemb er 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, to which additives or other substances may have been added, microplastics: solid plastic particles smaller than 5 mm and insoluble in water,
naturally occurring polymer: a polymer that occurs naturally in the environment and whose chemical structure has not been altered if it has been subjected to a chemical process or treatment or a physical mineralogical transformation,
making available on the market: each time a product is made available for distribution, consumption or use on the Swedish market in the course of a commercial activity, whether in return for payment or free of charge.
§ 4 a It is prohibited to make available on the market a cosmetic product that is intended to be rinsed off or spat out after being used on the head, hair, mucous membranes or teeth, and contains microplastics which have been added to cleanse, exfoliate or polish.
§ 4 a It is prohibited to make available on the market a cosmetic product that is intended to be rinsed off or spat out after being used on the head, hair, mucous membranes or teeth, and contains microplastics which have been added to cleanse, exfoliate or polish.
The ban does not apply to cosmetic products containing microplastics that only consist of naturally occurring polymers.
§ 4 b The Swedish Chemicals Agency may notify regulations on exemptions or, in individual cases, grant an exemption from the ban in § 4 a for cosmetic products containing microplastics, which are
§ 4 b The Swedish Chemicals Agency may notify regulations on exemptions or, in individual cases, grant an exemption from the ban in § 4 a for cosmetic products containing microplastics, which are
1. manufactured using naturally occurring polymers as a raw material, and
manufactured using naturally occurring polymers as a raw material, and
2. quickly broken down into monomers in the aquatic environment and do not pose any risk to aquatic organisms.
quickly broken down into monomers in the aquatic environment and do not pose any risk to aquatic organisms.
Cosmetic products that are lawfully sold in accordance with legislation in other Member States of the European Union or Turkey or lawfully manufactured in a State party to the Agreement on the European Economic Area shall be exempt, on the condition that said regulatory framework provides an equivalent level of protection.
1. This ordinance shall enter into force on [date] [month] 2018.
§ 5 Chemical products that wholly or partly consist of methylene chloride or tetrachloroethylene must not be marketed or transferred to consumers for individual use.
2. Despite the ban stipulated in § 4 a, existing stocks of cosmetic products that have been lawfully made available on the market prior to [the entry into force date] shall continue to be made available until [six months after the entry into force date].
The Swedish Chemicals Agency may issue regulations that goods containing methylene chloride or tetrachloroethylene must not be marketed or transferred to consumers for individual use.
On behalf of the Government
The ban on methylene chloride only applies if an equivalent ban does not already follow from point 59.1 of Annex XVII to Regulation (EC) No 1907/2006.
( )
This Ordinance shall enter into force on 1 July 2018.
( xx )
Despite the ban in § 4 a, existing stocks of cosmetic products that have lawfully been made available on the market before 1 July 2018, shall continue to be made available until the end of December 2018.
On behalf of the government
KAROLINA SKOG
Egon Abresparr
(Ministry of the Environment and Energy)
Norstedts Juridik AB
Elanders Sverige AB, 2018
3
1
4