1. PRELIMINARY
The European Commission on March 12, 2019 adopted the ‘Implementing Regulation on rules and procedures for the operation of unmanned aircraft’ along with the ‘Delegated Regulation on unmanned aircraft systems and on third-country operators of unmanned aircraft systems’ (“Regulations”) and its Annex. If objections are not raised by the EU Parliament or by the EU Council, the Regulations will be published by 2019. By 2022 the transitional period will be complete and the Regulations will be fully applicable.[1]
One can identify the following themes flowing through the document. This is also how this blog post is structured:
- Conformity assessment bodies (“CAB”);[2]
- Obligations of economic operators (“EO”);[3] and
- Market surveillance and border control.
2. CONFORMITY ASSESSMENT BODIES
Conformity assessment is the process of testing the conformity of a product with legislatively prescribed requirements.[4] Such assessment may be undertaken by the manufacturer itself as well as by a third-party CAB. Being independent from manufacturers, CABs add an element of credibility and neutrality to the assessment process. They also ensure a high degree of uniformity to the products which they certify. CABs may be private or publically owned companies, trade associations, consumer organisations, national standards bodies, or even government agencies.[5] CABs can act as the first, second or third stage of conformity assessment before a product is placed on the market.[6]
Accordingly, the Regulations provide for notifying CABs to undertake conformity assessment activities such as calibration, testing, certification and inspection.[7] This assessment is over and above the assessment carried out by manufacturers as laid out in Article 13 of the Regulations read with Parts 7, 8 and 9 of the Annex. As per Article 22 of the Regulations, CABs must be independent third-party organisations. Further, they cannot be stakeholders in the value chain of the designing, production, use or maintenance of UASs, amongst other functions, including any consultancy services which deal with UASs.[8] It is interesting that the Regulations allow business associations and professional federations representing these stakeholders to function as CABs, “on the condition of [their] independence and the absence of any conflict of interest….”.[9] It is commendable that industry players are being roped in to undertake limited regulatory functions. By doing so the government may leverage their expertise and market experience which will catalyse market growth. Further, it also leads to the creation of a competitive market for conformity assessment services since these services may be provided for a standard fee.[10] The involvement of these associations/federations ensure that best practices for conformity assurance percolate from CABs to manufacturers, who may find representation in some of these associations/federations. However, ensuring the neutrality of CABs is equally important to ensure that they carry credence.[11] To this end, the Regulations list out certain requirements for CABs to ensure their impartiality. The Regulations spell out the qualifications of personnel who will undertake the said assessment[12] and also make stipulations as to the resources that CABs should have to undertake such assessment.[13] Further, the Regulations clarify that the remuneration of top-level management of CABs and the personnel responsible for carrying out the assessment shall not be linked to the “number of assessments carried out or on the results of those assessments”.[14] The foresight and degree of prescriptive detail of the Regulations must be appreciated in this respect.
The Regulations go a step further and propose that member states designate independent notifying authorities (“NA”) governed by Section 4 to undertake “assessment and notification” of CABs.[15] Further, member states may designate national accreditation bodies[16] to “monitor” CABs. An additional bulwark for probity is introduced Article 20 which lists requirements to safeguard the impartiality and objectivity of NAs. We can therefore see multiple levels of checks and balances, firstly impartiality of CABs, secondly, oversight of CABs by NAs and thirdly, neutrality of NAs themselves.
3. OBLIGATIONS OF ECONOMIC OPERATORS
The Regulations define EOs to include the manufacturer, its authorised representative, the importer and the distributor.[17] The obligations placed on manufacturers, include, amongst others, drawing up technical documentation,[18] carrying out conformity assessment procedures[19], affixing CE markings and affixing class identification number to products.
It is noteworthy that the Regulations obligate manufacturers,[20] distributors[21] and importers[22] to inform market surveillance authorities (“MSA”)[23] if they have reason to believe that any of their products on the market are not in conformity with the requirements under the Regulations. The Regulations allow the national competent authorities of member states to call for the conformity demonstrating documentation from the manufacturers,[24] distributors[25] and importers[26] pursuant to a ‘reasoned request’. The Regulations thus seek to rope in private parties to assist national authorities in the performance of their functions which is bound to impact product compliance positively. The Regulations empower surveillance authorities to enquire from EOs as to who supplied a product to them or to whom they supplied a product for a period of ten years from the transaction.[27]
Similar technical and compliance related obligations as those placed on manufacturers are also placed on importers,[28] and distributors.[29] The Regulations also put in place a mechanism for inter se oversight amongst EOs by requiring downstream EOs (importers and distributors) to ensure that upstream EOs (manufacturers) have complied with their obligations. These provisions further strengthen compliance and deter manufacturers from cutting corners with respect to their obligations under the Regulations.
An interesting provision of the Regulations states that importers and distributors shall be considered manufacturers for the relevant chapter if they place a product on the market under their own name or trademark or modify the product already on the market in such a way that affects its compliance status.[30] This goes to establish compliance responsibility commensurate with any profit or initiative taken by certain EOs to earn profit.
4. MARKET SURVEILLANCE AND BORDER CONTROL
The Regulation proposes market surveillance and control of products entering the Union market, under Article 35. The MSAs of respective member states shall be responsible for evaluating any product which has been acted against by other member states or which they have reason to believe presents a risk to the health or safety of persons or to other aspects of public interest.[31]
The MSAs shall also be empowered to direct the respective EOs to take corrective action to make any non-compliant product, compliant, or to withdraw the product from the market or to recall it within a reasonable period. Additionally, the MSAs are required to inform the relevant notified bodies[32] as well as the Commission and other member states if they believe the non-compliance affects the latter’s jurisdiction as well.[33]
5. CONCLUSION
The Regulations will go a long way in establishing a uniform regulatory framework for UASs to be operated in the European Union as well as in ensuring the safety and privacy of its citizens with respect to such use. India has also recognised the importance of the regulation of UASs and accordingly India’s Directorate General of Civil Aviation (“DGCA”) published the ‘Requirements for Operation of Civil Remotely Piloted Aircraft System’ which is part of the Civil Aviation Requirements (“CAR”) announced under the provisions of Rule 15A and Rule 133A of the Aircraft Rules, 1937.[34] India may draw inspiration from some key provisions of the Regulations. In particular, India may explore the viability and desirability of CABs given the scale and diversity of Indian industry players, and regulatory capacity and bandwidth.
(Authored by Ratul Roshan, Associate, with inputs from Anirudh Rastogi, Founder at Ikigai Law)
[1] Civil drones (Unmanned aircraft), available at https://www.easa.europa.eu/easa-and-you/civil-drones-rpas (Last accessed on 05 April 2019).
[2] Refer Article 3 (11) of the Regulations.
[3] Refer Article 3 (17) of the Regulations.
[4] http://ec.europa.eu/growth/single-market/goods/building-blocks/conformity-assessment_en
[5] Conformity Assessment bodies, available at https://www.iso.org/sites/cascoregulators/01_3_conformity-assessment-bodies.html (Last accessed on 04 April 2019).
[6] Conformity Assessment bodies, available at https://www.iso.org/sites/cascoregulators/01_3_conformity-assessment-bodies.html (Last accessed on 04 April 2019).
[7] Refer Article 18 of the Regulations.
[8] Refer Article 22 (3) of the Regulations.
[9] Refer Article 22 (3) of the Regulations.
[10] Conformity Assessment bodies, available at https://www.iso.org/sites/cascoregulators/01_3_conformity-assessment-bodies.html (Last accessed on 04 April 2019).
[11] Conformity Assessment bodies, available at https://www.iso.org/sites/cascoregulators/01_3_conformity-assessment-bodies.html (Last accessed on 04 April 2019).
[12] Refer Article 22 (7) of the Regulations.
[13] Refer Article 22 (6) of the Regulations.
[14] Refer Article 22 (8) of the Regulations.
[15] Refer Article 19 (1) of the Regulations.
[16] Refer Article 19 (2) of the Regulations.
[17] Refer Article 19 (17) of the Regulations.
[18] Refer Article 17 of the Regulations.
[19] Refer Article 13 of the Regulations.
[20] Refer Article 6 (9) of the Regulations.
[21] Refer Article 9 (4) of the Regulations.
[22] Refer Article 8 (7) of the Regulations.
[23] Refer Article 3 (23) of the Regulations.
[24] Refer Article 6 (10) of the Regulations.
[25] Refer Article 9 (5) and the Regulations.
[26] Refer Article 8 (9) of the Regulations.
[27] Refer Article 8 (9) of the Regulations.
[28] Refer Article 8 of the Regulations.
[29] Refer Article 9 of the Regulations.
[30] Refer Article 10 of the Regulations.
[31] Refer Article 36 of the Regulations.
[32] Refer Article 36 of the Regulations.
[33] Refer Article 36 (2) of the Regulations.
[34] These rules were announced in exercise of the powers conferred by sections 5 and 7 and sub-section (2) of section 8 of the Aircraft Act, 1934 (XXII of 1934) and section 4 of the Indian Telegraph Act, 1885 (XIII of 1885), and in supersession of the Indian Aircraft Rules, 1920,
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