(Art. 2 para. 4 and 9 para. 2)
For the correct interpretation of Regulation (EU) No 528/20121, to which reference is made in this Ordinance, the following expressions, legislation and individual provisions correspond as set out below:
The expressions below used in Regulation (EU) No 528/2012 and in this Ordinance correspond as follows:
| European Union | Switzerland |
|---|---|
| Mixture | Preparation |
| Article | Object |
| Making available on the market | Placing on the market as defined in Article 4 paragraph 1 letter i of the Chemicals Act of 15 December 2000 |
| Placing on the market | Placing on the market for the first time |
| Micro-organism | Microorganisms as defined in Article 2 paragraph 2 letter d |
| Letter of access | Letter of access as defined in Article 2 paragraph 2 letter e |
| Receiving/evaluating competent authority | Notification Authority/assessment authorities |
| Simplified authorisation procedure | Simplified authorisation |
Where reference is made in this Ordinance to provisions of Regulation (EU) No 528/2012 that themselves refer to other EU law, the following Swiss law applies instead of the EU law:
| EU legislation | Swiss legislation |
|---|---|
| Rules on the transport of dangerous goods | Regulations concerning transport by post, rail, road, air, water and pipelines |
| Directive 98/24/EC | Legislation on the protection of workers |
| Directive 2004/37/EC | Legislation on the protection of workers |
| Directive 2008/98/EC | Waste Ordinance of 4 December 20152; Ordinance of 22 June 20053on the Movement of Wastes |
| Regulation (EC) No 850/2004 | Annexes 1.1, 1.9 and 1.16 ORRChem4 |
| Regulation (EC) No 689/2008 | PIC Ordinance of 10 November 20045 |
| Art. 31 of the REACH Regulation | Art. 20 ChemO6 |
| Art. 59 of the REACH Regulation | Annex 3 ChemO |
| Art. 24 of the CLP Regulation | Art. 14 ChemO |
| Annex V to Regulation (EU) No 528/2012 | Annex 10 |
The following expressions used in the EU acts referred to in the list in Annex 2 (Union list of approved active substances) correspond to the expressions used in this Ordinance as follows:
| European Union | Switzerland |
|---|---|
| Authorised for use in member states | Authorised for use in Switzerland |
| The member states evaluate | The assessment authorities evaluate |
| Maximum residue limits (MRL) | Maximum concentrations or limits |
Where reference is made in this Ordinance to provisions of EU implementing acts on approvals of active substances that themselves refer to other EU law, the following Swiss law applies instead of the EU law:
| EU legislation | Swiss legislation |
|---|---|
| Art. 5 and Annex VI of Directive 98/8/EC | Art. 11 and 17 OBP |
| Art. 19 and Annex VI of Regulation EU No 528/2012 | Art. 11 and 17 OBP |
| Regulations (EC) No 470/2009 and (EC) No 396/2005 | FDHA Ordinance of 16 December 2016 7 on the Maximum Residue Levels for Pesticides in or on Products of Plant and Animal Origin, FDHA Ordinance of 16 December 2016 8 on Residues of Pharmacologically Active Substances and Feed Additives in Foodstuffs of Animal Origin FeedO 9 |
| Regulation (EC) No 1935/2004 | Food Contact Materials Ordinance of 16 December 201610 |
See footnote to Art. 1b para. 3. ↩
SR 814.600 ↩
SR 814.610 ↩
SR 814.81 ↩
SR 814.82 ↩
[AS 2005 2721; 2007 821; 2009 401,805; 2010 5223; 2011 5227; 2012 6103,6659; 2013 201,2673,3041No I 3; 2014 2073Annex 11 No 1,3857.AS 2015 1903Art. 91]. See now: the O of 5 June 2015 (SR 813.11 ). ↩
SR 817.021.23 ↩
SR 817.022.13 ↩
SR 916.307 ↩
SR 817.023.21 ↩
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