Scope of the Law
§ 1 Scope
(1) This law applies when products of Tie Solution GmbH are made available, displayed, or first used on the market as part of a business activity.
(2) This law does not apply to
1. Antiques,
7. plant protection products within the meaning of Article 2(1) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing
3. Products that are exclusively designed for military use by their construction.
4. Food, feed, live plants and animals, products of human origin and products of plant and animal origin directly related to their future reproduction,
5. Medical devices within the meaning of Article 2(1) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1; L 117, 3.5.2019, p. 9; L 334, 27.12.2019, p. 165), as amended by Regulation (EU) 2020/561 (OJ L 130, 24.4.2020, p. 18), and within the meaning of Article 2(2) of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176; L 117, 3.5.2019, p. 11; L 334, 27.12.2019, p. 167), as amended, in each case as currently in force.
6. Enclosures, such as mobile pressure equipment, packaging and tanks, for the transport of dangerous goods, to the extent that they are subject to traffic regulations, and
7. Plant protection products within the meaning of Article 2(1) of Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1; OJ L 45, 18.2.2020, p. 81), as last amended by Regulation (EU) 2019/1009 (OJ L 170, 25.6.2019, p. 1).
(3) The provisions of this Act shall not apply insofar as
1. there are special provisions for the products covered by this law in other legal regulations and
2. these other legal regulations regulate certain aspects of market provision more specifically.
(4) Within the framework of the provisions of the United Nations Convention on the Law of the Sea of 10 December 1982 (Federal Law Gazette 1994 II p. 1799), this law also applies in the exclusive economic zone.
Act on the placing of products on the market * (Product Safety Act - ProdSG)
For the purposes of this law, the following definitions apply:
For the purposes of this Act,
1.Accreditation the confirmation by a national accreditation body that a conformity assessment body meets the requirements specified in harmonized standards and, where applicable, additional requirements including those in relevant sectoral accreditation systems, to perform a specific conformity assessment activity,
2. Displaying or demonstrating products for advertising purposes,
3. Exhibitor means any natural or legal person who displays a product,
4. Placing on the Union market means any supply of a product for distribution, consumption or use on the Union market, whether in return for payment or free of charge, in the course of a commercial activity,
5. Intended use
a) the use for which a product is intended according to the information provided by the person placing it on the market, or
b) the use which can be reasonably expected for a product, taking into account its design and construction.
6.Authorized Representative any natural or legal person established within the European Union who has been mandated in writing by the manufacturer to perform certain tasks on their behalf in relation to the applicable Union harmonization legislation or the requirements of this law,
7.CE marking is the marking by which the manufacturer declares that the product meets the applicable requirements set out in the harmonisation legislation of the European Union which require the affixing of the CE marking.
8. Importer means any natural or legal person established within the European Union who places a product on the market.
9.Import means the first making available of a product on the Union market; 'placing on the market' shall be construed accordingly and shall include the holding of a product for the purpose of offering it for sale, distribution or use on the Union market.
10.serious risk that a product poses a risk where the ratio between the probability of a hazard causing harm and the severity of the harm, based on a risk assessment and taking into account the normal and foreseeable use of the product, requires prompt intervention by market surveillance authorities, even if the risk has no immediate effect,
11. Fulfillment service provider means any natural or legal person who, as part of a business activity, offers at least two of the following services: storage, packaging, addressing and shipping of products for which it has no ownership rights, excluding postal services within the meaning of Article 2(1) of Directive 97/67/EC of the European Parliament and of the Council of 15 December 1997 on common rules for the development of the internal market of Community postal services and the improvement of quality of service (OJ L 15, 21.1.1998, p. 14; OJ L 23, 30.1.1998, p. 39), as last amended by Directive 2008/6/EC (OJ L 52, 27.2.2008, p. 3), parcel delivery services within the meaning of Article 2(2) of Regulation (EU) 2018/644 of the European Parliament and of the Council of 18 April 2018 on cross-border parcel delivery services (OJ L 112, 2.5.2018, p. 19) and all other postal or freight transport services,
12.CB body a conformity assessment body to which the authority responsible for authorising the affixing of the CE marking has given the power to affix the GS mark,
13. Dealer any natural or legal person in the supply chain who places a product on the market, with the exception of the manufacturer and importer,
14. Harmonized standard means a standard within the meaning of Article 2(1)(c) of Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Decision 87/95/EEC of the Council and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12), as amended by Directive (EU) 2015/1535 (OJ L 241, 17.9.2015, p. 1).
15. Manufacturer means any natural or legal person who manufactures or has a product designed or manufactured and markets that product under their own name or trademark; the term manufacturer also includes anyone who
a) affixes their name, trademark or other distinctive mark to a product in the course of their business and presents themselves as the manufacturer, or
b) reprocessing a product or influencing the safety characteristics of a consumer product and subsequently making it available on the market,
16. Placing on the market means the first making available of a product on the Union market.
17. Conformity assessment the procedure for assessing whether specific requirements for a product, process, service, system, person or body have been met,
18. Conformity assessment body a body that carries out conformity assessment activities including calibrations, tests, certifications and inspections,
19. Notified body a conformity assessment body,
a) the authority granting the authorization has granted authorization to perform conformity assessment tasks in accordance with the regulations issued under Section 8 (1) to implement or carry out European Union legislation, and has been notified by the authority granting the authorization to the European Commission and the other Member States of the European Union, or
b) notified bodies that have been notified by a Member State of the European Union or another contracting state of the Agreement on the European Economic Area to the European Commission and the other Member States of the European Union pursuant to a European legal act,
20. Notification the authority granting the authorization notifies the European Commission and the other Member States of the European Union that a conformity assessment body can perform conformity assessment tasks in accordance with the regulations issued pursuant to Section 8(1) for the implementation or enforcement of European Union legislation,
21. Product a good, substance or mixture that has been manufactured through a production process,
22. Risk the combination of the probability of a hazard causing harm and the severity of the potential harm.
23. Withdrawal from the market any measure aimed at preventing a product in the supply chain from being made available on the Union market,
24. Recall any measure aimed at obtaining the return of a product already made available to the end user,
25. consumer product means a new, used or reconditioned product intended for consumers or which, under reasonably foreseeable conditions, may be used by consumers, even if not intended for them; a consumer product also includes a product provided to the consumer as part of a service,
26.Usable when a product can be used as intended without the need for additional parts; a product is also considered usable when
a) all parts from which it is to be assembled are put into circulation together by one person,
b) it only needs to be installed or connected, or
c) it is put into circulation without the parts that are usually procured separately and inserted for the intended use,
27. foreseeable use means the use of a product in a way that is not intended by the person putting it into circulation, but is reasonably foreseeable.
28.Economic operator means the manufacturer, authorized representative, importer, distributor, fulfillment service provider or any other natural or legal person who has obligations related to the manufacture of products, their placing on the market or putting into service in accordance with the relevant legal provisions.
Tie Solution GmbH refers to the latest version of the Federal Ministry of Justice, current edition.