Explosives Working Group4 November 2014

Notified Bodies and NANDO

Norma McGovern, DG ENTR.C1 – Internal Market and its International Dimension

Contents

1. NANDO and NANDO-Input

2. Notifications under Directive 93/15/EEC

3. New Civil Explosives Directive

4. Criteria and obligations for NBs

5. Notification of a NB

6. Processing of a notification

7. Current issues

8. Documents and References

1. NANDO and NANDO-Input

NANDO web site• Public web site on Europa, for information• Lists all conformity assessment bodies notified under EU harmonisation

legislation• Search criteria: country, legislation, body (number/type), 'free search'

(key word), withdrawn/expired notifications• Lists notifying authorities and accreditation bodies

NANDO-Input• Secure web-based notification tool used by NAs• Access by ECAS password• Responsibility for content lies with NA - date of notification is the date

of submission by NA

2. Notifications under Directive 93/15/EEC

• 14 notifications currently in NANDO.

• MS: BE, BG, CZ, DE, ES, FI, FR, HR, HU, PL, RO, SE, SK, UK

• No NBs: AT, CY, DK, EE, IE, IT, LT, LU, LV, MT, PT, SI, (EFTA: IS/NO)

• Withdrawn/expired: 1: NL

3. New Civil Explosives Directive

• The new Directive 2014/28/EU repeals and replace Directive 93/15/EEC with effect from end of transposition period – 20 April 2016.

• This means that notifications under the old directive will be withdrawn from the NANDO database, and NBs will have to be newly notified under the new directive.

• This does not necessarily mean new ID numbers.

• Notifications will follow the criteria set out in the Directive (next slide).

• NANDO-Input will be set up to receive the notifications by end of 2014.

• NANDO contact persons in the NAs will be informed by e-mail.

4. Criteria and obligations for NBs

• Art 28: Requirements relating to NBs• Legal personality• Independent 3rd party organisation• Professional integrity & technical and professional competence• Transparency of procedures• Technical & administrative means• Personnel – training and know-how• Impartiality• Liability insurance• Professional secrecy• Training and participation in NB coordination group

Criteria and obligations for NBs (contd.)

Art 30: Subsidiaries and subcontracting• Inform NA; full responsibility for tasks; agreement of client

Art 32: Notification procedure• Electronic notification tool: NANDO-Input• Details of notification: products, conformity assessment modules,

articles/annexes of legislation; validity period; assessment of competence of the NB (accredited/not accredited); references to standards where appropriate

• Art. 5(2) of Regulation 765/2008; objection period

Art 36: Operational obligations of NBs• Proportionate manner - taking due account of size of undertaking – not to

place unnecessary administrative burdens on SMEs• Safety not compromised• Require manufacturer to take corrective measures/withdrawal of certificates

Criteria and obligations for NBs (contd.)

Art 38: Information obligations of NBs• Notify NA of withdrawals of certificates, etc.• Notify changes in scope of NB ...• Respond to request for info from Market Surveillance authorities• Respond to request for info on activities, cross-border, subcontracting ...

Art 39 and 40: Exchange of experience and coordination groups

5. Notification of a NB

1. CAB submits application to its notifying authority (NA)

2. NA submits a draft notification via NANDO-Input

3. Information required:a) Details of the organisationb) Details of the notification – products, modules, validity periodc) Details of accreditation – formally accredited by the NAB or

not?

6. Processing of a notification

Draft notification received by the Commission via NANDO-Input

Notifications with accreditationi. consultation of Commission sectoral desk officerii. possible query to NA iii. validation/publication on the NANDO web siteiv. time frame: aligned/not aligned*

6 (a). Processing of a notification

Notifications without accreditationi. consultation of Commission sectoral desk officer AND the

other Member States (Article 5(2) of Regulation EC/765/2008)

ii. translation of supporting documentationiii. possible query from desk officer or MS, forwarded to NA iv. validation/publication on the NANDO web sitev. time frame: minimum 2 months

7. Current issues

• Discussed at the most recent IMP meeting:

Duration in time of notifications Survey of current notifications in NANDO with 'unlimited' duration,

and not updated since 2007 (824 found) Affects reliability of information on the web site MS responsibility to ensure continuous competence of NBs

Ensuring timely notifications of NBs under aligned legislation (2014-2016)

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8. Documents and References

NANDO web site

NLF – Regulation No (EC) 765/2008 and Decision 768/2008/EC

IMP (CERTIF) documents: CERTIF 2013-11-REV1 – Time frames for notification of NBs following the entry into force

of the Alignment Package

CERTIF 2013-04 REV2 – Ensuring continuous competence of notified bodies

CERTIF 2013-08 – NANDO procedure for notification of notified bodies that are not accredited by a national accreditation body

CERTIF 2010-08 REV1 - Notification without accreditation (Art. 5.2 of Regulation 765/2008)