In the European Union, Article 4(5) of Regulation (EC) 765/2008 stipulates for all member states that the accreditation of conformity assessment bodies is a sovereign activity. The “accreditation” is thus directly and specifically connected with the exercise of official authority within the meaning of Art. 51 TFEU (cf. judgment ECJ, of 06.05.2021, Case C-142/20, Analisi G. Caracciolo ./. Accredia, ECLI:EU:C:2021:368). In Germany, only one authority is responsible nationwide for all accreditations of conformity assessment bodies according to Article 4(1) of Regulation (EC) No. 765/2008. According to § 1 Para. 1 AkkStelleGBV, this is the German Accreditation Body (DAkkS).
Consequently, neither private bodies nor unauthorised foreign bodies may carry out the activity of accreditation vis-à-vis conformity assessment bodies based in Germany, neither in the context of initial accreditation nor in the context of monitoring conformity assessment bodies. Already the activity of carrying out accreditations within the meaning of Article 2 No. 10 of Regulation (EC) No. 765/2008 or giving the appearance of carrying out accreditation by confirming the competence of conformity assessment bodies or in any other way is prohibited according to § 1a AkkStelleG.
Accordingly, accreditation activities of foreign accreditation bodies in Germany are prohibited without an applicable exemption according to Article 7 in conjunction with Article 6(3) and Article 4(2) of Regulation (EC) No. 765/2008. Pursuant to § 1a (3) AkkStelleG, the DAkkS may issue the necessary orders and take the necessary measures to prevent or eliminate inadmissible accreditations.
Persons who participate in Germany as assessors or otherwise in the granting of an unauthorised foreign accreditation of a conformity assessment body with its registered office in Germany may commit the offence of criminal presumption of authority pursuant to Section 132 of the German Criminal Code (StGB), which is punishable by imprisonment for up to two years or a fine.
Nevertheless, it may be necessary in special constellations to verify the existence of the exceptional circumstances according to Article 7(1)(2) of Regulation (EC) No. 765/2008 or to organise a joint accreditation procedure (joint assessment) between the DAkkS and an accreditation body from a third country on the basis of WTO law in order to reduce or mitigate barriers to trade.
The department of Accreditation Governance, Research and Innovation is the contact for accreditation bodies wishing to operate in Germany or for conformity assessment bodies seeking to acquire accreditation from a third country. Upon request, the department provides a binding statement on the admissibility of the procedure and coordinates the necessary steps for a joint assessment or an observation according to Article 7(2) Regulation (EC) No. 765/2008, if admissible.
Application review for accreditations from third countries
Application procedure
Applications for accreditation with review and binding application assessment for scopes with reference to third countries or with review of the admissibility of the activity of foreign accreditation bodies in Germany and the acquisition of an accreditation with the participation of foreign accreditation bodies are to be submitted by conformity assessment body based in Germany in written form with description of the facts to DAkkS (written form requirement).
The application review is subject to a fee in accordance with the Annex to § 1 AkkStelleGebV, tariff item 1.1.1.
Country of domicile principle in the EU
According to Article 1(1) Regulation (EC) No 765/2008, a conformity assessment body wishing to apply for accreditation needs to turn to the national accreditation body of the Member State in which it is based or the national accreditation body to which that Member State has recourse under Article 4(2) Regulation (EC) No 765/2008. These provisions also do not allow a conformity assessment body to be accredited by a body based in a third country in order to carry out its activities in the European Union (ECJ, judgment of 6 May 2021, Analisi G. Caracciolo, C-142/20, EU:C:2021:368, para. 32). Accreditation covers all worldwide locations and scopes of the conformity assessment body, including abroad. Within the EU, the accreditation bodies apply the coordination procedure according to EA 2/13 if assessments outside their own national territory become necessary in another EU or EEA member state.n.
Joint Assessment with third countries
In the current state of development of WTO world trade law, situations may arise where, in the absence of other trade agreements, the activity of a conformity assessment body based in Germany in a third country market appears to make sense for the German economy, but these constellations are not covered by the exceptions of Article 7 (1,2) of Regulation (EC) No. 765/2008, or other legal obstacles prevent legal recognition of DAkkS accreditation in the export destination country. Due to this situation in non-European markets, DAkkS offers a procedure which ensures that an accreditation for a third country can be obtained while still complying with the legal requirements of Regulation (EC) No. 765/2008.
In the process, two accreditation procedures are conducted, which for each jurisdiction (EU + third country) must initially fulfil the requirements of their jurisdiction independently. However, in order to reduce duplicate costs and time delays and to ensure international coherence of both procedures, both procedures are linked via subcontracts in accordance with the specifications of ISO/IEC 17011 and the requirements of the respective international accreditation organization so the assessment is not duplicated. This procedure requires that the DAkkS and the accreditation body from the third country are effectively linked via an MLA and that the accreditation body has been formally authorised as such by its country of domicile. These prerequisites are verified by the DAkkS in each individual case.
The procedure can be represented schematically as follows:
Timely application
The application for accreditation at DAkkS including an application review to examine the admissibility of the activities of foreign accreditation bodies in Germany and the acquisition of an accreditation involving foreign accreditation bodies must therefore be made before a contract is concluded with a foreign accreditation body. Otherwise, the prohibition is already fulfilled.
Dependent branches of foreign companies
If a conformity assessment body based in a third country wants to operate a dependent location in Germany (critical location) which does not make any legally regulated offers into the EU internal market and therefore wants to continue carrying the third country accreditation, DAkkS is subcontracted by the accreditation body of the third country according to para. 6.4.4 ISO/IEC 17011. DAkkS carries out the assessment on the German territory as a subcontractor and reports to the accreditation body in the third country. The accreditation body from the third country is not allowed to operate on German territory.
If the body wants to offer legally regulated conformity assessment activities in the EU internal market, the exceptional constellation described above is not permissible. The body in Germany must be established as an independent company without group control and requires DAkkS accreditation.