Proposal for a Council Decision on the signature on behalf of the Community of an Agreement between the European Community and Japan on Mutual Recognition in relation to Conformity Assessment
Date: 2001-02-09
Institutions: European Commission
Subjects: Japan, agreement (EU), mutual recognition principle, quality label

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 09.02.2001
COM(2001) 25 final

2001/0036 (ACC)
2001/0037 (ACC)

Proposal for a

COUNCIL DECISION

on the signature on behalf of the Community of an Agreement between the European
Community and Japan on Mutual Recognition in relation to Conformity Assessment

Proposal for a

COUNCIL DECISION

on the conclusion of an Agreement between the European Community and Japan on
Mutual Recognition in relation to Conformity Assessment

(presented by the Commission)

EXPLANATORY MEMORANDUM

I. The Agreement

On the basis of the negotiating directives issued by the Council on 21.9.92. the European
Commission has negotiated and initialled an agreement on the mutual recognition of
conformity assessment (Mutual Recognition Agreement, or MRA) with Japan. A Text of the
Agreement initialled in December 2000 is annexed.

This memorandum provides an assessment of the Agreement in the light of the negotiating
directives approved by the Council, and recommends that the Council decide to approve the
signature and the conclusion of the Agreement by means of Council decisions to that effect.

I.1 Assessment of the Agreement

The Commission considers that the initialled Agreement is in conformity with the Council's
negotiating directives, takes account of the views expressed by the 133 MRA Working Group,
which gave detailed advice to the Commission during the negotiations, and provides benefits
to the European Community.

Sufficient confidence exists between the Parties to the Agreement to allow them to proceed.

I.1.1 Framework Agreement

The Agreement consists of a framework agreement and a series of sectoral annexes. An
article-by-article assessment of the framework follows:

Pre-amble : This sets out the principal objective of the mutual recognition agreement, which
is thefacilitation of trade between the parties.

Article 1: Definitions: these are self-explanatory. One should note, however, that there are
separate sets of definitions for the GMP and GLP annexes.

Article 2: General Obligations: this sets out the obligation of each Party to accept the
conformity assessment results carried out to its requirements by the other Party, according to
the terms of the sectoral annexes. Notably, the provision establishes acceptance of product
certifications of each Party. This Article also establishes the link between the basic
obligations of the Agreement and its sectoral annexes.

Article 3: Sectoral Coverage:
the conformity assessment
procedures to which the Agreement applies are specified in the individual sectoral annexes,
and describes the content of the annexes.

this Article provides that

Article 4: Designating Authorities: this is a key provision requiring designating authorities
to have the necessary formal powers over the bodies they designate. This article thus provides
a treaty guarantee that Japan has the necessary authority to designate, suspend or withdraw
bodies.

Article 5: Verification of Compliance By Conformity Assessment Bodies: this Article
establishes the right for one Party to challenge the compliance of bodies in the other Party.
Verification will be carried out by the Party in whose territory the CAB is located. This article
also ensures that bodies of each Party are monitored so as to be able, continuously, to
correctly interpret the regulatory requirements of the other Party.

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Articles 6 and 7: A CAB will be suspended where disagreement over its status has been
confirmed by the Joint Committee, unless otherwise decided by that Committee. As advised
by Member States in the 133 Committee MRA Group, the right of verification has been
closely circumscribed to prevent it from being carried out routinely or unilaterally.

Article 8: Joint Committee: this Article requires the establishment of a Joint Committee to
administer the Agreement on behalf of the Parties. Duties of the Joint Committee include
formally adopting changes to the Sectoral annexes to add or remove conformity assessment
bodies, and discussing divergences of view. This article also contains provisions on exchange
of information.

Article 9 sets out detailed procedures for designation of bodies and the right of the other Party
to contest such designations according to certain rules.

Article 10: Safeguards: this Article provides that an importing Party retains all powers under
its domestic law, and within its territory, to take measures to protect health, safety or the
environment. These powers must be exercised in accordance with the principle of non-
discrimination. This article also provides for emergency verification of GMP and GLP
facilities.

Article 8, 9 and 15: Market Access: New conformity assessment procedures applying to
covered products or requirements will be brought within the scope of the Agreement, unless
jointly decided otherwise, so as to preserve negotiated market access benefits.

Article 11: Agreements with other countries: this Article provides that Mutual Recognition
Agreements between Parties to this Agreement and other countries shall have no force in
regard to the other Party to this Agreement.

Article 13: Confidentiality Clause: this is a standard clause

Articles 12 and 14: these are standard institutional and legal provisions. It should be noted
that the Agreement is of unlimited duration, and that there is no scope for a Party unilaterally
to terminate an individual sectoral annex.

I.1.2 The Sectoral Annexes

In the following, an assessment is given of the content of each sectoral annex in terms of its
coverage, the type of mutual recognition arrangements envisaged for the sector, and the trade
and other implications. In making this assessment, the Commission has kept in mind the
following elements:

a)

b)

c)

d)

whether the sectoral annex provides for genuine mutual recognition, i.e. whether all
relevant conformity assessment procedures for a particular sector have been
captured;

the level of trade between the Community and Japan for the sectors and products
covered;

the views expressed by Member States and European industry groups on the benefits
of mutual recognition;

the precedential nature (if any) of arriving at a mutual recognition agreement with
Japan in the sectors covered;

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e)

overall consistency with Community policy objectives in the field of standardisation,
certification, designation of conformity assessment bodies and the removal of
technical barriers to trade.

The sectoral assessment
Agreement.

is followed by an overall appreciation of the benefits of the

The Commission draws Member States' attention to the trade figures for each covered sector
in the Annex to this note. These figures show that for every sector concerned, the Community
has a rough trade balance with Japan. Third party certification (the subject of the MRA)
applies most commonly to industrial products at the higher end of technology, in respect of
which both the Community and Japan are major exporters.

A priori, this may indicate that the trade facilitation benefits of the Mutual Recognition should
accrue to both the Community and Japan. We note however, that trade flows only give a
partial picture of the likely benefits. The balance of benefits depends on additional factors, in
particular the following:

a)

b)

the range of products within a sector subject to third party certification. Obviously, if
in a given sector one Party has more comprehensive certification requirements, the
trade facilitation benefits to the other i.e. exporting Party may be proportionately
greater;

the complexity and accessibility of the conformity assessment requirements of each
Party, including the extent to which each Party applies internationally recognised
standards or technical requirements for the sector in question. Generally, this is not a
major issue in the case of Japan which has adopted international standards and
regulations fairly systematically.

The Commission notes that industrial groups consulted throughout the negotiations, such as
Eurobit and Orgalime, while supporting the agreement, have not always been able to quantify
the costs or time taken to obtain conformity assessment of their products in third countries,
including Japan. It is therefore not feasible in every case to determine the extent of savings in
time, cost or market opportunity of the arrangements set out in this agreement. This may only
be possible once the agreement has been in operation for some time. What can be ascertained
however is whether we have addressed industry's concern that any agreement provide
reciprocal levels of market access, in terms of conformity assessment procedures.

The Agreement also presents important advantages from the point of transparency, market
access, avoidance of duplication especially of cost, and general facilitation of trade. This is of
particular importance for small and medium sized companies.

On the basis of a rough calculation it is estimated that this Agreement will create cost savings
for the exporting industry of at least 20 M Euro and an equivalent amount in terms of cost
savings to exporters to the EC, some part of which will be passed on to European importers or
consumers.

Where relevant, the above factors are taken into account in the assessment of each sectoral
annex.

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Pharmaceuticals Good Manufacturing Practice (GMP)

This annex establishes mutual recognition of each Party's inspections of pharmaceutical sites
according to the GMP standards of each, which are effectively equivalent.

Recognition of inspection results and the ensuing certificate of GMP compliance removes the
need for companies in each Party to be inspected by the authorities of the other Party. Each
party accepts the GMP certificate issued by the exporting Party's authority and the products
traded do not need further batch testing and control upon import.

European industry and Member States' inspection authorities (Working Group on Inspection
and control of medicinal productsand the Pharmaceutical Committee) have been consulted at
every step of the negotiation and support the arrangements negotiated. The Community is an
important exporter to Japan (see Annex).

The scope of the Agreement is as broad as possible and covers all medicinal products, which
have undergone one or a series of manufacturing processes, e.g. fabrication, repackaging,
labelling, testing, wholesaling to which GMP applies. Veterinary immunologicals are not
covered.

The sectoral annex applies to all pharmaceutical products subject to GMP in either Party. This
permits inspections to be carried out against each Party's domestic GMP requirements in most
cases. In (marginal) cases where a product is classed as a pharmaceutical in one Party but not
the other, the agreement enables the exporting party's inspection authority to certify GMP to
the importing Party's requirements on a voluntary basis.

The Agreement also lists the applicable legislation and relevant certifying authorities. It sets
up a Joint Sub Committee to oversee preparatory work which must be completed and agreed
before this sectoral annex can come into effect; This is the equivalent of confidence building
period.

While providing mutual benefits to pharmaceutical companies, and some savings to
inspection authorities, the present agreement also establishes mechanisms for longer-term
cooperation between respective inspection authorities which will not only ensure the
agreement continues to be properly applied, but will stimulate further harmonisation
initiatives in other fields of medicines controls, such as Good Clinical and Laboratory
Practices

Industrial Chemicals, Good Laboratory practice (GLP)

This annex establishes mutual recognition of studies and data generated therefrom produced
by the test facilities of the other Party provided that these facilities are recognised to be in
conformity with the OECD principles of Good Laboratory Practice and participate in the
compliance monitoring programme of that party. To that end the Parties also recognise the
equivalence of each other’s compliance monitoring programmes. Recognition of inspection
results and the ensuing compliance with the GLP principles removes the need for companies
in each Party to be inspected by the authorities of the other Party. Both Parties have accepted
the decisions and recommendations of the OECD Council on Mutual Acceptance of Data
(MAD) in 1981 and on compliance monitoring for Good Laboratory Practice in 1989 and
have co-operated closely in the relevant OECD Working Group.

The Parties will exchange annually lists of recognised test facilities which specify the area of
expertise of each test facility for which GLP compliance has been established. Only the

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studies and data generated therefrom in the areas for which compliance with GLP is certified
will have to be recognised.

The studies and data generated therefrom are used by the parties for administrative purposes
during the evaluation process before the marketing and use of the substances for which the
studies have been carried out. The MRA thus reduces the costs and time delays due to the
testing of chemical substances and preparations and facilitates market access. The Annex
covers all non-clinical health and environmental safety studies for the products which are
explicitly specified: industrial chemicals, pesticides, medicinal products, veterinary drugs,
food additives, animal feed additives, cosmetics. The Commission considers that the MRA is
to the advantage of manufacturers and Exporters of the Community intending to placing their
products on the Japanese market.

The proposed arrangement also supersedes and extends to all Member States the coverage of
what were some limited ‘memoranda of understanding’ between some individual Japanese
ministries and a number of Member States for certain chemical products.

Electrical Safety

This Annex covers the testing and certification requirements set out in the EC's Low Voltage
Directive and corresponding Japanese legislation and regulations.

European industry groups have been consulted on the proposed MRA and have expressed
support provided that we ensure that any agreement provide for reciprocity of market access
and not lead to the introduction of new and more onerous requirements. Given the existing
openness of the EC regime, and the fact that the necessary Japanese legislation is covered
under the sectoral annex, these requirements have clearly been met. While manufacturers self
certification exists in the EC third party certification is required for certain categories of
products in Japan. As a result of the Agreement one certificate issued by a designated
European CAB will now suffice. There are therefore clear advantages in the Agreement from
an EC perspective.

Electromagnetic Compatibility (EMC)

In view of the "horizontal" application of EMC requirements to a wide range of electrical,
machinery and telecommunications products, coverage of the EMC phenomenon in the MRA
is necessary to achieve the objective of covering all relevant conformity assessment
procedures.

Each Party agrees to recognise all of the other Party’s reports, certificates and Technical
Construction Files, as required under
respective legislation, without any further
assessment of the products. Both Parties also agree to recognise each other’s suppliers
declaration of compliance as required under their respective legislation.

their

Telecommunications Terminal Equipment

There is a special annex on Telecommunications equipment but both sectoral annexes on
electrical safety and electromagnetic compatibility also apply. These annexes apply to all
telecommunications terminal equipment (TTE) regulated under the relevant Community
RTTE Directive and the corresponding Japanese legislation.

The Agreement provides for
recognition of the conformity assessment certificates of
Conformity Assessment Bodies designated by the Parties in so far as applicable. The

6

Conformity Assessment Bodies will be required to comply with the criteria and standards set
out in the regulatory requirements of the other Party (a list of Designating and Approval
Bodies and Designated Bodies with an indication of the products and procedures for which
the latter have been designated, have or will be set out in the sectoral annex).

European industry organisations have been consulted extensively on the MRA negotiations
and have supported the objectives provided that access by means of recognition to all
Japanese conformity assessment systems, including product approvals, is achieved. In this
connection, the agreement provides for reciprocal recognition of all conformity assessment
procedures including final certification without further product assessment by the importing
party.

I.1.3 Relations with EFTA States, members of the European Economic Area

In accordance with the general information and consultation procedures set out in the EEA
Agreement and Protocol 12 of the said Agreement, the Commission has kept EFTA / EEA
States regularly informed about developments in the negotiations and has informed them on
the final result of the negotiations. Japan has not at this stage accepted to negotiate a similar
agreement with EEA / EFTA.

I.1.4 Overall Appreciation

The Commission considers that the proposed MRAs create an acceptable balance of benefits
for all parties overall, when all sectors are taken together. The overall trade balance with
Japan would also suggest that the Agreement will work in favour of EC exporters. In all
sectors the Community has secured effective market access - in terms of access to all
mandatory procedures of the other party. Japan has accepted the Community's approach of
reciprocally recognising not only testing, but also certificates and approvals of conformity to
the other's requirements. This is a significant development. The agreement will allow
Community exporters, if they so choose, to test and certify their products to Japanese
requirements prior to export, and then access those markets without any further conformity
assessment
facilitate Community exports. European industry
federations have been consulted on the agreement and have supported them.

requirements. This will

The Commission has received indications that a large number of EC conformity assessment
bodies would be interested to work in the framework of this Agreement, and this indicates
both their technical capacity and economic interest in the Agreement.

In several sectors the agreement caters for the further development of the parties' regulatory
regimes, with the aim of ensuring that future rules do not undermine the benefits of the
agreement. And in several sectors, the agreement will help to promote wider acceptance of the
Community’s or an international regulatory approach and technical requirements.

II. The Draft Council Decisions

A proposal for two Council decisions on the signature and the conclusion of the Agreement is
attached.

The legal basis for both decisions are Articles 133 and 300 of the Treaty.

The decision concerning the conclusion of the Agreement must also establish the appropriate
Community procedure to enable the Commission, assisted by the 133 Committee (Mutual
Recognition), to represent the Community in the Joint Committee and where appropriate in

7

the Joint Sub-Committee established by the Sectoral Annexes. It should furthermore provide
that the Community position in that Joint Committee and in the Joint Sub-Committee in case
of certain technical decisions, including in some cases the amendment of the annexes, be
determined, in conformity with Article 300, paragraph 4 of the Treaty, by the Commission in
consultation with the 133 Committee.

Such decisions are limited to issues concerned with implementation over time, in particular
amending the references to the regulations applicable to covered sectors; amending the
annexes further to decisions to recognise, suspend, remove, or alter the scope of activity of
conformity assessment bodies or designating authorities in the Agreement. In all other cases,
the position of the Community shall be established by the Council, acting on the basis of a
proposal from the Commission.

The Commission therefore proposes that the Council adopts the appended decisions.

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2001/0036 (ACC)

Proposal for a

COUNCIL DECISION

on the signature on behalf of the Community of an Agreement between the European
Community and Japan on Mutual Recognition in relation to Conformity Assessment

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article
133, in conjunction with the first sentence of the first subparagraph of Article 300 (2) thereof,

Having regard to the proposal from the Commission1,

Whereas subject to its possible conclusion at a later date, the Agreement on Conformity
Assessment initialled in Brussels on 11 December 2000 should be signed,

HAS DECIDED AS FOLLOWS:

Sole Article

Subject to a possible conclusion at a later date, the President of the Council is hereby
authorised to designate the person empowered to sign, on behalf of the Community, the
Agreement with Japan on Mutual Recognition in regard to Conformity Assessment.

Done at Brussels, […]

For the Council
The President
[…]

1 OJ C […], […], p. […].

9

2001/0037 (ACC)

Proposal for a

COUNCIL DECISION

on the conclusion of an Agreement between the European Community and Japan on
Mutual Recognition in relation to Conformity Assessment

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article
133 in conjunction with Article 300, paragraph (2), first subparagraph, first sentence,
paragraph (3), first subparagraph, first sentence, and paragraph (4) thereof,

Having regard to the proposal of the Commission,

Whereas:

(1)

(2)

(3)

(4)

The Agreement on Mutual Recognition in relation to Conformity Assessment between
initialled on 11 December 2000, has been
the European Community and Japan,
negotiated and should be approved,

This Agreement has been signed, on behalf of the European Community, on […]
subject to its possible conclusion at a later date, in accordance with Decision …/…/EC
of the Council of […],

implementation have been attributed to the Joint Committee
Certain tasks for
established by the Agreement, involving in certain cases the power to amend the
Sectoral Annexes thereto;

The appropriate internal procedures should be established to ensure the good
functioning of the Agreement, and whereas it is therefore necessary to delegate to the
Commission the power to proceed to certain technical amendments of the Agreement
and to take certain decisions for its implementation.

HAS DECIDED AS FOLLOWS:

Article 1

The Agreement on Mutual Recognition in relation to Conformity Assessment between the
European Community and Japan, including its Annexes is hereby approved on behalf of the
European Community.

The text of the Agreement and the Annexes are attached to this Decision.

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The President of the Council shall, on behalf of the Community, transmit the note provided
for in Article 14 of the Agreement2.

Article 2

Article 3

1.

2.

The Commission shall represent the Community in the Joint Committee (art. 8) and
in any Sub-Committees (art. 8.2) that are established under it, assisted by the special
committee designated by the Council. The Commission shall proceed, after
consultation with this committee, to the proposals for registrations, provision of lists
terminations, suspensions, withdrawals, appointments of experts,
of
notifications, exchange of information, and requests for verifications referred to in
Articles 5, 6, 7, 8, 9, 10 of the Agreement and the equivalent provisions of its
Sectoral Annexes.

facilities,

The position to be taken by the Community in the Joint Committee or if appropriate
by any Sub-Committees shall be determined by the Commission following
consultation of the above mentioned special committee, with regard to:

a) adoption of the rules of procedure, in accordance with article 8.2;

b) registration of CABs in accordance with art. 9.1;

c) verification of the compliance of conformity assessment bodies and related
decisions, in accordance with articles 5 and 7 of the Agreement;

d) verification of facilities in accordance with articles 5, 7 and 10 of the Agreement;

e) the transitional arrangements associated with implementation of the Agreement
(art. 2.9 of sectoral annex on GMP);

f) definition of emergencies in accordance with article 10.2 (b).

3.

In all other cases the position to be taken by the Community in the Joint Committee
or a Sub-Committee shall be determined by the Council, acting by a qualified
majority on a proposal from the Commission.

Done at Brussels,

For the Council
The President

2

The date of entry into force of the Agreement will be published in the Official Journal of the European
Communities.

11

Draft

Agreement on Mutual Recognition between

Japan and the European Community

12

AGREEMENT ON MUTUAL RECOGNITION
BETWEEN
JAPAN AND THE EUROPEAN COMMUNITY

The European Community and Japan (hereinafter referred to as "the Parties");

Considering the traditional friendly relations that exist between Japan and the European
Community;

Recognising the significance of mutual recognition of the results of conformity assessment
procedures in facilitating market access and promoting trade between the Parties;

Considering the common interest in enhancing product quality, with a view to ensuring the
health and safety of the public and protecting the environment;

Recognising the OECD principles of Good Laboratory Practice (GLP);

Recalling that long and fruitful cooperative activities of Japan and the European Community
have made contributions
to international development and harmonisation of Good
Manufacturing Practice (GMP) requirements;

Being aware of the positive contribution that mutual recognition agreements can make to
encouraging international harmonisation of standards; and

Bearing in mind the obligations of the Parties as Members of the World Trade Organisation,
inter alia, of their obligations under the Agreement on Technical
and being conscious,
Barriers to Trade (hereinafter referred to as the “WTO Agreement on Technical Barriers to
Trade”) included in Annex 1A, and the Agreement on Trade-Related Aspects of Intellectual
Property Rights (hereinafter referred to as the “WTO Agreement on Trade-Related Aspects of
the Marrakesh Agreement
Intellectual Property Rights”)
Establishing the World Trade Organisation (hereinafter
the “WTO
Agreement”);

included in Annex 1C of

referred to as

Have agreed as follows:

1. For the purposes of this Agreement:

ARTICLE 1

(a) the term "conformity assessment procedure" means any procedure to determine, directly or
indirectly, whether products or processes fulfil relevant technical requirements set out in the
applicable laws, regulations and administrative provisions of a Party;

(b) the term "conformity assessment body" means a body which conducts conformity
assessment procedure, and the term “registered conformity assessment body” means the
conformity assessment body registered pursuant to Article 9 of this Agreement;

(c) the term "designation" means the designation of conformity assessment bodies by a
Designating Authority of a Party pursuant
regulations and
administrative provisions of that Party;

to the applicable laws,

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(d) the term "Designating Authority" means an authority of a Party with the power to
designate, monitor, withdraw the designation of, suspend the designation of, and withdraw the
suspension of the designation of the conformity assessment bodies in its territory that conduct
conformity assessment procedures based upon requirements set out in the applicable laws,
regulations and administrative provisions of the other Party;

(e) the term “criteria for designation” means the criteria which conformity assessment bodies
of a Party are required to fulfil in order to be designated by the Designating Authority of that
Party, and other relevant conditions which designated conformity assessment bodies are
required to continuously fulfil after the designation, as set out
in the applicable laws,
regulations and administrative provisions of the other Party specified in the relevant Sectoral
Annex;

(f) the term “confirmation” means the confirmation of the compliance of manufacturing
facilities or test facilities (hereinafter referred to as “facilities”) with the criteria for
confirmation by a Competent Authority of a Party pursuant to the applicable laws, regulations
and administrative provisions of that Party;

(g) the term “Competent Authority” means an authority of a Party with the power to conduct
inspection or study audits on facilities in its territory to confirm their compliance with the
criteria for confirmation set out
in the applicable laws, regulations and administrative
provisions of that Party;

(h) the term “criteria for confirmation” means the criteria which a facility of a Party is
required to continuously fulfil in order to be confirmed by the Competent Authority of the
Party, as set out in the applicable laws, regulations and administrative provisions of that Party
specified in the relevant Sectoral Annex; and

(i) the term “verification” means an action to verify in the territories of the Parties, by such
means as audits or inspections, compliance with the criteria for designation or the criteria for
confirmation by a conformity assessment body or a facility respectively.

2. Any term used in this Agreement, unless otherwise defined herein, has the meaning
assigned to it in the ISO / IEC Guide 2: 1996 Edition, “Standardisation and related activities –
General vocabulary”.

ARTICLE 2

1. Each Party shall accept, in accordance with the provisions of this Agreement, the results of
conformity assessment procedures required by the applicable laws,
regulations and
administrative provisions of that Party specified in the relevant Sectoral Annex, including
that are conducted by the registered conformity
certificates and marks of conformity,
assessment bodies of the other Party.

2. Each Party shall accept, in accordance with the provisions of this Agreement:

a) the confirmation of facilities conducted by the Competent Authorities of the other Party
based upon the results of verification and in accordance with the criteria for confirmation
stipulated in the laws, regulations and administrative provisions of that other Party as
specified in the relevant Sectoral Annex; and

b) the data generated by confirmed facilities of the other Party.

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ARTICLE 3

1. This Agreement applies to designation of conformity assessment bodies, conformity
assessment procedures for products or processes, and to confirmation of facilities and data
generated by them, covered by its Sectoral Annexes. Sectoral Annexes may consist of Part A
and Part B.

2. Part A of Sectoral Annexes shall include, inter alia, provisions on scope and coverage.

3. Part B of Sectoral Annexes shall set out the following matters:

(a) the applicable laws, regulations and administrative provisions of each Party concerning the
scope and coverage;

(b) the applicable laws, regulations and administrative provisions of each Party stipulating the
requirements covered by this Agreement, all the conformity assessment procedures covered
by this Agreement to satisfy such requirements and the criteria for designation of conformity
assessment bodies, or the applicable laws, regulations and administrative provisions of each
Party stipulating the criteria for confirmation of the facilities covered by this Agreement; and

(c) the list of Designating Authorities or Competent Authorities.

ARTICLE 4

1. Each Party shall ensure that Designating Authorities have the necessary power to designate,
monitor (including verification), withdraw the designation of, suspend the designation of and
withdraw the suspension of the designation of the conformity assessment bodies that conduct
conformity assessment procedures based upon the requirements set out in the applicable laws,
regulations and administrative provisions of the other Party specified in the relevant Sectoral
Annex.

2. Each Party shall ensure that Competent Authorities have the necessary power to conduct, in
accordance with its applicable laws, regulations and administrative provisions, verification of
facilities to confirm their compliance with the criteria for confirmation set out
in the
applicable laws, regulations and administrative provisions of that Party specified in the
relevant Sectoral Annex.

ARTICLE 5

through appropriate means such as audits,

1. Each Party shall ensure,
inspections or
monitoring, that the registered conformity assessment bodies fulfil the criteria for designation
set out in the applicable laws, regulations and administrative provisions of the other Party
specified in the relevant Sectoral Annex. When applying the criteria for designation of the
conformity assessment bodies, Designating Authorities of a Party should take into account the
bodies’ understanding of and experience relevant to the requirements set out in the applicable
laws, regulations and administrative provisions of the other Party.

2. Each Party shall, in accordance with its applicable laws, regulations and administrative
provisions and through appropriate means such as study audits, inspections or monitoring,
ensure that the confirmed facilities fulfil the criteria for confirmation set out in the applicable

15

laws, regulations and administrative provisions of that Party specified in the relevant Sectoral
Annex.

3. Each Party may request the other Party, by indicating in writing a reasoned doubt on
whether a registered conformity assessment body or a confirmed facility complies with the
criteria for designation or the criteria for confirmation set out
in the applicable laws,
regulations and administrative provisions specified in the relevant Sectoral Annex,
respectively, to conduct verification of the conformity assessment body or the facility in
accordance with the laws, regulations and administrative provisions of that other Party.

4. Each Party may, upon request, participate as an observer in the verification of conformity
assessment bodies conducted by the Designating Authorities or the verification of facilities
conducted by the Competent Authorities of the other Party, with the prior consent of such
conformity assessment bodies or such facilities respectively, in order to maintain a continuing
understanding of that other Party’s procedures for verification.

in accordance with the procedures to be determined by the Joint
5. The Parties shall,
Committee to be established pursuant
to Article 8, exchange information on methods,
including accreditation systems, used to designate the conformity assessment bodies and to
ensure that the registered conformity assessment bodies fulfil the criteria for designation and
on methods to ensure that the confirmed facilities fulfil the criteria for confirmation.

6. Each Party should encourage its registered conformity assessment bodies to cooperate with
the conformity assessment bodies of the other Party.

ARTICLE 6

1. In case of suspension of the designation of a registered conformity assessment body, the
Party whose Designating Authority has suspended the designation shall immediately notify
the other Party and the Joint Committee to that effect. The registration of that conformity
assessment body shall be suspended from the time of receipt of the notification by the co-
chairman of that other Party on the Joint Committee. The other Party shall accept the results
of the conformity assessment procedures conducted by that conformity assessment body prior
to the suspension of the designation.

2. In case of lifting of the suspension of the designation of a registered conformity assessment
body, the Party whose Designating Authority has lifted the suspension of the designation shall
immediately notify the other Party and the Joint Committee to that effect. The suspension of
the registration of that conformity assessment body shall be lifted from the time of receipt of
the notification by the co-chairman of that other Party on the Joint Committee. The other
Party shall accept the results of the conformity assessment procedures conducted by that
conformity assessment body from the time of lifting of the suspension of the registration.

ARTICLE 7

1. Each Party may contest the compliance with the criteria for designation or the criteria for
confirmation set out
in the applicable laws, regulations and administrative provisions
specified in the relevant Sectoral Annex by a registered conformity assessment body or a
confirmed facility of the other Party, respectively. Such contestation shall be notified to the
Joint Committee and to that other Party in writing with an objective explanation of the reason

16

for the contestation. The Joint Committee shall discuss such contestation within 20 days
following the date on which such notification is made.

2. Where the Joint Committee decides to conduct a joint verification, it will be conducted in a
timely manner by the Parties with the participation of the Designating Authority that
designated the contested conformity assessment body and with the prior consent of the
conformity assessment body. The result of such joint verification shall be discussed in the
Joint Committee with a view to resolving the issue as soon as possible.

3. The registration of the contested conformity assessment body shall be suspended 15 days
after the date on which the notification is made or on the date on which the Joint Committee
decides to suspend the registration, whichever is the sooner. The registration of the contested
conformity assessment body shall remain suspended until the Joint Committee decides to lift
the suspension of the registration of the conformity assessment body. In the event of such
suspension, the contesting Party shall accept the results of conformity assessment procedures
conducted by that conformity assessment body prior to the date of suspension.

4. The Joint Committee will decide on the actions to be taken by a Party or Parties with a
view to resolving issues concerning the contestation of facilities as soon as possible.

5. The contesting Party shall not be obliged to accept the confirmation of and the data
generated by the contested facility from the date on which the co-chairman of the other Party
on the Joint Committee receives the notification referred to in paragraph 1 above until the
date on which the Joint Committee decides otherwise.

ARTICLE 8

1. A Joint Committee made up of representatives of both Parties shall be established on the
date of the entry into force of this agreement, as a body responsible for the effective
functioning of this Agreement.

2. The Joint Committee shall take decisions and adopt recommendations by consensus. It
shall meet at the request of either Party under the co-chairmanship of both Parties. The Joint
Committee may establish sub-committees and delegate specific tasks to such sub-committees.
It shall adopt its rules of procedure.

3. The Joint Committee may consider any matter related to the operation of this Agreement.
In particular, it shall be responsible for and/or decide on:

(a) registration of a conformity assessment body, suspension of registration of a conformity
assessment body, lifting of suspension of registration of a conformity assessment body, and
termination of registration of a conformity assessment body;

(b) establishment and, unless otherwise decided, publication on a Sector by Sector basis, of
lists of the registered conformity assessment bodies and the confirmed facilities;

(c) establishment of appropriate modalities of information exchange referred to in this
Agreement; and

(d) appointment of experts from each Party for the joint verification referred to in paragraph 2
of Article 7 and sub-paragraph (c) of paragraph 1 of Article 9.

17

4. If any problem arises to the interpretation or application of this Agreement, the Parties shall
seek an amicable solution through the Joint Committee.

5. The Joint Committee is responsible for coordinating and facilitating the negotiation of
additional Sectoral Annexes.

6. Each Party shall provide the other Party and the Joint Committee, at least annually, with a
list of the confirmed facilities.

7. Any decision made by the Joint Committee will be notified promptly in writing to each
Party.

8. The Parties shall, through the Joint Committee:

(a) specify and communicate to each other the applicable articles or annexes contained in the
laws, regulations and administrative provisions set out in the Sectoral Annexes;

(b) exchange information concerning the implementation of the applicable laws, regulations
and administrative provisions specified in the Sectoral Annexes;

(c) notify each other of any scheduled changes in the laws, regulations and administrative
provisions related to this Agreement prior to their entry into force; and

(d) notify each other of any scheduled changes concerning their Designating Authorities,
the registered conformity assessment bodies and the confirmed
Competent Authorities,
facilities.

ARTICLE 9

1. The following procedure shall apply to the registration of a conformity assessment body:

(a) Each Party shall make a proposal that a conformity assessment body of that Party
designated by its Designating Authority be registered under this Agreement, by presenting its
proposal in writing, supported by necessary documents, to the other Party and the Joint
Committee.

(b) The other Party shall consider whether the proposed conformity assessment body complies
with the criteria for designation set out in the applicable laws, regulations and administrative
provisions of that other Party specified in the relevant Sectoral Annex and indicate its position
regarding the registration of that conformity assessment body within 90 days from the receipt
of the proposal referred to in sub-paragraph (a) above. In such consideration, such other Party
the proposed conformity assessment body complies with the
should assume that
aforementioned criteria. The Joint Committee shall take a decision whether to register the
proposed conformity assessment body within 90 days from the receipt of the proposal.

(c) In the event that the Joint Committee cannot decide to register the proposed conformity
assessment body, the Joint Committee may decide to conduct a joint verification or to request
the proposing Party to conduct a verification of the proposed body with the prior consent of
such body. After the completion of such verification, the Joint Committee may reconsider the
proposal.

18

2. The proposing Party shall provide the following information in its proposal for registration
of a conformity assessment body and keep such information up to date:

(a) the name and address of the conformity assessment body;

(b) the products or processes the conformity assessment body is authorised to assess;

(c) the conformity assessment procedures the conformity assessment body is authorised to
conduct; and

(d) the designation procedure and necessary information used to determine the compliance of
the conformity assessment body with the criteria for designation.

3. Each Party shall ensure that its Designating Authority withdraws the designation of a
registered conformity assessment body when the Designating Authority considers that the
conformity assessment body no longer complies with the criteria for designation set out in the
applicable laws, regulations and administrative provisions of the other Party specified in the
relevant Sectoral Annex.

4. Each Party shall propose the termination of the registration of its conformity assessment
body when that Party considers that the conformity assessment body no longer complies with
the criteria for designation set out in the applicable laws, regulations and administrative
provisions of the other Party specified in the relevant Sectoral Annex, or the Designating
Authority of that Party withdraws the designation of a conformity assessment body. Proposals
for terminating the registration of that conformity assessment body shall be made to the Joint
Committee and the other Party. The registration of that conformity assessment body shall be
terminated upon receipt of the proposal by the co-chairman of that other Party on the Joint
Committee, unless otherwise determined by the Joint Committee.

5. In the case of a registration of a new conformity assessment body, the other Party shall
accept
the results of conformity assessment procedures conducted by that conformity
assessment body from the date of the registration. In the event that the registration of a
conformity assessment body is terminated, the other Party shall accept the results of the
conformity assessment procedures conducted by that conformity assessment body prior to the
termination, without prejudice to paragraph 1 of Article 6 and paragraph 3 of Article 7.

ARTICLE 10

1. Nothing in this Agreement shall be construed to limit the authority of a Party to take
measures it considers appropriate, for protecting health, safety or the environment or
prevention of deceptive practices.

for

the purpose of deciding whether

2. (a) The Competent Authority of a Party may conduct a verification on manufacturing
facilities of the other Party with the prior consent of that other Party and of the manufacturing
facilities concerned,
the
confirmation of the manufacturing facilities concerned and the data generated by them
pursuant to paragraph 2 of Article 2, where an emergency as defined in sub-paragraph (b) of
this paragraph takes place. Such verification shall be carried out in a manner not inconsistent
with the laws and regulations of that other Party and in accordance with the modalities to be
decided pursuant to sub-paragraph (b) of this paragraph. The Party shall use the information
obtained by its Competent Authority in connection with such verification only for the purpose
above. The Competent Authority of that other Party may join such verification.

to continue to accept

19

(b) The definition of the emergency and the modalities of such verification referred to in sub-
paragraph (a) of this paragraph will be decided by the Joint Committee as part of the
preparatory work to be done in accordance with the provisions of the relevant Sectoral Annex.

ARTICLE 11

1. Without prejudice to paragraph 2 of Article 2, nothing in this Agreement shall entail mutual
acceptance of the standards or technical regulations of the Parties.

2. Nothing in this Agreement shall be construed to entail an obligation upon a Party to accept
the result of the conformity assessment procedures of any third country.

3. Nothing in this Agreement shall be construed so as to affect the rights and obligations that
either Party has as a Member to the WTO Agreement, including the WTO Agreement on
Technical Barriers to Trade and the WTO Agreement on Trade-Related Aspects of
Intellectual Property Rights.

ARTICLE 12

This Agreement shall apply to the territory of Japan and to the territories in which the Treaty
establishing the European Community is applied under the conditions laid down in that
Treaty.

ARTICLE 13

Neither Party shall disclose any information obtained under this Agreement as confidential,
unless otherwise required under the laws or regulations of each Party.

ARTICLE 14

1. This Agreement shall enter into force on the first day of the second month following the
date on which the Parties exchange diplomatic notes informing each other that their respective
internal procedures necessary to give effect to this Agreement have been completed.

2. Either Party may terminate this Agreement by giving the other Party six months written
notice.

ARTICLE 15

1. The Sectoral Annexes to this Agreement are an integral part of this Agreement.

2. In case of conflict between the provisions of Part A of a Sectoral Annex and Articles 1 to
15 of this Agreement, the provisions of Part A of the Sectoral Annex shall prevail.

3. Laws, regulations and administrative provisions, Designating Authorities or Competent
Authorities may be added to, deleted from or changed in Part B of the Sectoral Annexes by
agreement between the Parties, in conformity with their applicable domestic procedures. They
shall not change the scope and coverage stipulated in paragraph 1 of Part A of each Sectoral
Annex unless they amend this Agreement.

20

4. If a Party introduces new or additional conformity assessment procedures within the same
product coverage to satisfy the requirements set out in the applicable laws, regulations and
administrative provisions specified in the relevant Sectoral Annex, the relevant lists contained
in Part B of that Sectoral Annex shall be changed to set out the applicable laws, regulations
and administrative provisions stipulating such new or additional conformity assessment
procedures, in accordance with the procedures set out in paragraph 3 of Article 15.

This Agreement and its Annexes are drawn up in two originals in the Danish, Dutch, English,
Italian, Japanese, Portuguese, Spanish and Swedish
Finnish, French, German, Greek,
languages. In case of divergence the English and Japanese versions shall prevail over the
other language versions.

IN WITNESS WHEREOF,
Agreement.

the undersigned, being duly authorised, have signed this

Done at ……, this ……day of ……

For the Council
The President

21

ANNEX

SECTORAL ANNEX

ON

TELECOMMUNICATIONS TERMINAL EQUIPMENT

AND

RADIO EQUIPMENT

22

Part A

SCOPE AND COVERAGE

applies

1. This Sectoral Annex
all
telecommunications terminal equipment and radio equipment, which in European Community
and Japan respectively are subject to conformity assessment procedures conducted by the
conformity assessment body, as set out in the laws, regulations and administrative provisions
of each Party specified in Section I of Part B of this Sectoral Annex.

assessment

conformity

procedures

for

to

2. It is understood that the term “amendment” referred to in Part B of this Sectoral Annex
includes the following cases that:

(a) a Party entirely or partially changes its applicable laws, regulations and / or administrative
provisions listed in Part B of this Sectoral Annex, whether those names are changed or not;

(b) a Party terminates its applicable laws, regulations and /or administrative provisions listed
in Part B of this Sectoiral Annex and adopts new laws, regulations and / or administrative
provisions substituting the previous laws, regulations and / or administrative provisions,
whether the previous names are changed or not; and

(c) a Party incorporates the whole or relevant part of its applicable laws, regulations and / or
administrative provisions listed in Part B of this Sectoral Annex into other laws, regulations
and / or administrative provisions.

23

Part B

SECTION I

THE APPLICABLE LAWS, REGULATIONS AND ADMINISTRATIVE
PROVISIONS STIPULATING TELECOMMUNICATIONS TERMINAL
EQUIPMENT AND RADIO EQUIPMENT

EUROPEAN COMMUNITY

JAPAN

1999/5/EC of

Directive
the European
Parliament and of the Council of 9 March
and
1999
telecommunications terminal equipment and
the mutual recognition of their conformity
and amendments thereto.

equipment

radio

on

Telecommunications Business Law (Law No.
86, 1984) and amendments thereto.

Ordinance concerning Technical Conditions
Compliance Approval and Certification of
the Type for Terminal Equipment (Ordinance
and
of
Telecommunications No. 14, 1999)
and
amendments thereto.

the Ministry

Posts

of

Radio Law (Law No. 131, 1950) and
amendments thereto.

Ordinance concerning Technical Regulations
Conformity Certification of Specified Radio
Equipment (Ordinance of the Ministry of
Posts and Telecommunications No. 37, 1981)
and amendments thereto

24

SECTION II

THE APPLICABLE LAWS, REGULATIONS AND ADMINISTRATIVE
PROVISIONS STIPULATING THE REQUIREMENTS AND THE CONFORMITY
ASSESSMENT PROCEDURES

EUROPEAN COMMUNITY

JAPAN

Directive 1999/5/EC of the European
Parliament and of the Council of 9
March 1999 on radio equipment and
telecommunications terminal equipment
and the mutual
their
conformity and amendments thereto.

recognition of

For electrical safety:

Council Directive 73/23/EEC of 19
February 1973 on the harmonisation of
the laws of Member States relating to
electrical equipment designed for use
within
and
this
amendments
Directive applies to equipment covered
by this Sectoral Annex

limits
insofar as

thereto,

voltage

certain

For electromagnetic compatibility:

Council Directive 89/336/EEC of 3 May
1989 on the approximation of the laws
to
of Member
States
and
electromagnetic
amendments
this
Directive applies to equipment covered
by this Sectoral Annex

compatibility

insofar as

thereto,

relating

Telecommunications Business Law (Law
No. 86, 1984) and amendments thereto.

Ordinance concerning Terminal Facilities
etc. (Ordinance of the Ministry of Posts
and Telecommunications No. 31, 1985)
and amendments thereto

concerning

Technical
Ordinance
and
Conditions Compliance Approval
Certification of the Type for Terminal
Equipment (Ordinance of the Ministry of
Posts and Telecommunications No. 14,
1999) and amendments thereto

Radio Law (Law No. 131, 1950) and
amendments thereto

Ordinance concerning Regulating Radio
Equipment (Ordinance of the Ministry of
Posts and Telecommunications No. 18,
1950) and amendments thereto

Technical
concerning
Ordinance
Regulations Conformity Certification of
Specified Radio Equipment (Ordinance of
and
the
Telecommunications No. 37, 1981) and
amendments thereto

Ministry

Posts

of

25

SECTION III

DESIGNATING AUTHORITIES

EUROPEAN COMMUNITY

JAPAN

are

Designating Authorities of the European
following
Community
authorities of the Member States of the
European Community or
authorities
succeeding them.

the

Belgium

Institut belge des services postaux et des
télécommunications

Designating Authorities of Japan are the
authorities
following
succeeding them:

authorities

or

For Directive 1999/5/EC of the European
Parliament and of the Council of 9 March
1999
and
radio
on
terminal equipment
telecommunications
and the mutual
their
recognition of
conformity and amendments thereto:

equipment

Belgisch instituut voor postdiensten en
telecommunicatie

Ministry of Public Management, Home
Affairs, Post and Telecommunication

For EMC aspects:

Ministère des Affaires Economiques

Ministerie van Economische Zaken

Denmark:

Telestyrelsen

Germany:

Bundesministerium für Wirtschaft

Greece:

of
Ministry
Communications

Transport

and

Spain:

Ministerio de Fomento

France:

Ministère de l’économie, des finances et
de l’industrie

Ireland:

Department of Transport, Energy and
Communications

Italy:

For Council Directive 89/336/EC of 3
May 1989 on the approximation of
the
the Member States relating to
laws of
electromagnetic compatibility and Council
Directive 73/23/EEC of 19 February 1973
on the harmonisation of
the laws of
relating to electrical
Member States
equipment designed for use within certain
voltage limits and amendments thereto:

Ministry of Public Management, Home
Affairs, Posts and Telecommunications

Ministry of Economy, Trade and Industry

26

Ministero dell’Industria, del Commercio
e dell’Artigianato

Luxembourg:

Administration
Télécommunications

des

Netherlands:

Postes

et

De Minister van Verkeer en Waterstaat

Austria:

Bundesministerium für Wissenschaft
und Verkehr

das

Communicações

de

Portugal:

Instituto
Portugal

Finland:

Liikennneministeriö/Trafikministeriet

Sweden:

Under the authority of the Government
of Sweden: Styrelsen för ackreditering
och teknisk kontroll (SWEDAC)

United Kingdom:

Department of Trade and Industry

27

SECTION IV:

THE APPLICABLE LAWS, REGULATIONS AND ADMINISTRATIVE
PROVISIONS STIPULATING THE CRITERIA FOR DESIGNATION

The criteria to be applied by Japan in
designating Conformity Assessment
Bodies to assess products against the
European Community’s
requirements

The criteria to be applied by the
European Community in designating
Conformity Assessment Bodies to assess
products against Japanese
requirements

Directive 1999/5/EC of the European
Parliament and of the Council of 9
March 1999 on radio equipment and
telecommunications terminal equipment
and the mutual
their
conformity and amendments thereto

recognition of

Council Directive 73/23/EEC of 19
February 1973 on the harmonisation of
the laws of the Member States relating
to electrical equipment designed for use
within
and
amendments thereto

voltage

certain

limits,

Council Directive 89/336/EEC of 3 May
1989 on the approximation of the laws
relating to
of
electromagnetic
and
amendments thereto.

the Member States

compatibility

Telecommunications Business Law (Law
No. 86, 1984) and amendments thereto

concerning

Technical
Ordinance
Conditions Compliance Approval
and
Certification of the Type for Terminal
Equipment (Ordinance of the Ministry of
Posts and Telecommunications No. 14,
1999) and amendments thereto

Radio Law (Law No. 131, 1950) and
amendments thereto

Ordinance
Technical
concerning
Regulations Conformity Certification of
Specified Radio Equipment (Ordinance of
and
the
Telecommunications No. 37, 1981) and
amendments thereto

Ministry

Posts

of

affixing and use of

Council Decision 93/465/EEC of 22
July 1993 concerning the modules for
the various phases of the conformity
assessment procedures and the rules for
the
the CE
conformity marking, which are intended
in
to
technical
the
be
and
directives
harmonisation
amendments thereto, to be taken into
account

used

28

SECTORAL ANNEX

ON

ELECTRICAL PRODUCTS

29

PART A

SCOPE AND COVERAGE

1. This Sectoral Annex applies to conformity assessment procedures for all electrical products
which in European Community and Japan respectively are subject to conformity assessment
procedures conducted by the conformity assessment body, as set out in the laws, regulations
and administrative provisions of each Party specified in Section I of Part B of this Sectoral
Annex.

2. It is understood that the term “amendment” referred to in Part B of this Sectoral Annex
includes the following cases that:

(a) a Party entirely or partially changes its applicable laws, regulations and / or administrative
provisions listed in Part B of this Sectoral Annex, whether those names are changed or not;

(b) a Party terminates its applicable laws, regulations and /or administrative provisions listed
in Part B of this Sectoral Annex and adopts new laws, regulations and / or administrative
provisions substituting the previous laws, regulations and / or administrative provisions,
whether the previous names are changed or not; and

(c) a Party incorporates the whole or relevant part of its applicable laws, regulations and / or
administrative provisions listed in Part B of this Sectoral Annex into other laws, regulations
and / or administrative provisions.

30

PART B

SECTION I: THE APPLICABLE LAWS, REGULATIONS AND
ADMINISTRATIVE PROVISIONS STIPULATING ELECTRICAL PRODUCTS

European Community

Japan

73/23/EEC of

Council Directive
19
February 1973 on the harmonisation of the
laws of
the Member States relating to
electrical equipment designed for use within
certain voltage limits, and amendments
thereto, excluding equipment falling within
the
the Sectoral Annex on
Telecommunications Terminal Equipment
and Radio Equipment

scope of

to

the

regard

With
electromagnetic
compatibility aspects of the above products,
Council Directive 89/336/EEC of May 1989
on the approximation of the laws of the
Member States relating to electromagnetic
compatibility and amendments thereto

Electrical Appliance and Material Safety
Law (Law No. 234, 1961) and amendments
thereto

Cabinet Order of the Electrical Appliance
and Material Safety Law (Cabinet Order,
No. 324, 1962) and amendments thereto

31

SECTION II: THE APPLICABLE LAWS, REGULATIONS AND
ADMINISTRATIVE PROVISIONS STIPULATING THE REQUIREMENTS AND
THE CONFORMITY ASSESSMENT PROCEDURES

European Community

Japan

73/23/EEC of

Council Directive
19
February 1973 on the harmonisation of the
laws of
the Member States relating to
electrical equipment designed for use within
certain voltage limits, and amendments
thereto

Council Directive 89/336/EEC of 3 May
1989 on the approximation of the laws of the
Member States relating to electromagnetic
thereto,
compatibility,
insofar
to
this Directive
equipment covered by this Sectoral Annex

and amendments

applies

as

Electrical Appliance and Material Safety
Law (Law No. 234, 1961) and amendments
thereto

Ordinance of the Electrical Appliance and
Material Safety Law (Ministerial Ordinance
of the Ministry of International Trade and
Industry, No. 84, 1962) and amendments
thereto

Ordinance
Technical
concerning
Requirements for Electrical Appliances and
the
Materials
Ministry of International Trade and Industry,
No. 85, 1962) and amendments thereto

(Ministerial Ordinance of

for

Regulations

Ordinance
Working
concerning Technical Requirements
for
Electrical Appliances and Materials (Public
Utilities Department, Agency of Natural
Resources
of
International Trade and Industry, No. 192,
thereto, which
1975)
concerning
implements
Technical Requirements
for Electrical
Appliances and Materials

Energy, Ministry

and amendments

the Ordinance

and

32

SECTION III: DESIGNATING AUTHORITIES

European Community

Japan

Designating Authorities of
the European
Community are the following authorities of
the Member States
the European
Community or authorities succeeding them

of

Ministry of Economy Trade and Industry or
an authority succeeding this ministry

Belgium

Ministère des Affaires Economiques

Ministerie van Economische Zaken

Denmark

Boligministeriet

For EMC aspects:

Telestyrelsen

Germany

Bundesministerium für Arbeit
Sozialordnung

und

For EMC aspects:

Bundesministerium für Wirtschaft und
Technologie

Greece

Ministry of Development

Spain

Ministerio de Industria y Energia

France

Ministère de l’Economie, des finances et
de l’industrie

Ireland

Department of Enterprise and Employment

33

Italy

Ministero dell’Industria, del Commercio
e dell’Artigianato

Luxembourg

Ministère des Transports

Netherlands

Staat der Nederlanden

Austria

Bundesministerium für wirtschaftliche
Angelegenheiten

Portugal

Under the authority of the Government
of Portugal:

Instituto Português da Qualidade

Finland

Kauppa-ja teollisuusministeriö

Handels-och industriministeriet

Sweden

Under the authority of the Government
of Sweden:

Styrelsen för ackreditering och teknisk
kontroll (SWEDAC)

United Kingdom

Department of Trade and Industry

34

SECTION IV : THE APPLICABLE LAWS, REGULATIONS AND
ADMINISTRATIVE PROVISIONS STIPULATING THE CRITERIA FOR
DESIGNATION

The criteria to be applied by Japan in
designating Conformity Assessment
Bodies to assess products against the
European Community’s requirements

The criteria to be applied by the
European Community in designating
Conformity Assessment Bodies to assess
products against Japan’s requirements

73/23/EEC of

19
Council Directive
February 1973 on the harmonisation of the
laws of
the Member States relating to
electrical equipment designed for use within
certain voltage limits, and amendments
thereto

Council Directive 89/336/EEC of 3 May
1989 on the approximation of the laws of the
Member States relating to electromagnetic
compatibility and amendments thereto

of

the

conformity

Council Decision 93/465/EEC of 22 July
1993 concerning the modules for the various
phases
assessment
procedures and the rules for the affixing and
use of the CE conformity marking, which
are intended to be used in the technical
harmonization directives and amendments
thereto, to be taken into account

Electrical Appliance and Material Safety
Law (Law No. 234, 1961) and amendments
thereto

Cabinet Order of the Electrical Appliance
and Material Safety Law (Cabinet Order,
No. 324, 1962) and amendments thereto

Ordinance of the Electrical Appliance and
Material Safety Law (Ministerial Ordinance
of the Ministry of International Trade and
Industry, No. 84, 1962) and amendments
thereto

35

SECTORAL ANNEX

ON

GOOD LABORATORY PRACTICE

(GLP)

FOR CHEMICALS

36

1. This Sectoral Annex applies to:

PART A

(a) the confirmation of the compliance of test facilities with the principles of GLP for the
testing of chemicals, being either substances or preparations, as set out
in the laws,
regulations and administrative provisions of each Party specified in Section I of Part B of this
Sectoral Annex; and,

(b) the acceptance of the data generated by confirmed test facilities.

2. (a) For the purpose of this Sectoral Annex:

(i) “criteria for confirmation” are the principles of GLP as stipulated in the laws, regulations
and administrative provisions of each Party specified in Section III of Part B of this Sectoral
Annex and that are consistent with Annex II of the OECD Council Decision of 12 May 1981
[C(81)30 (Final)] as amended by OECD Council Decision of 26 November 1997 [C(97) 186
(Final)]; and

(ii) “verification” means the monitoring of the compliance of a test facility with the principles
of GLP by procedures such as study audits and inspections that are set out in the laws,
regulations and administrative provisions of each Party specified in Section III of Part B of
this Sectoral Annex and that are consistent with OECD Council Decision – Recommendation
of 2 October 1989 [C(89) 87(Final)], and in particular its Annexes I and II, as amended by the
OECD Council Decision of 9 March 1995 [C(95)8(Final)].

(b) For the purpose of this Sectoral Annex, any term, unless otherwise defined in this
Agreement, has the meaning assigned to it in the “OECD Principles of Good Laboratory
Practice” as contained in Annex II of the OECD Council Decision of 12 May 1981 [C (81) 30
(Final)], the “Guides for Compliance Monitoring Procedures for Good Laboratory Practice”
as contained in Annex I of the OECD Council Decision – Recommendation of 2 October
1989 [C (89) 87 (Final)], the GLP Consensus Document “The Application of the GLP
Principles to Field Studies” (OECD Series on Principles of Good Laboratory Practice and
Compliance Monitoring, Number 6), and all amendments made thereto.

(c) It is understood that the term “amendment” referred to in Part B of this Sectoral Annex
includes the following cases that:

(i) a Party entirely or partially changes its applicable laws, regulations and / or administrative
provisions listed in Part B of this Sectoral Annex, whether those names are changed or not;

(ii) a Party terminates its applicable laws, regulations and /or administrative provisions listed
in Part B of this Sectoiral Annex and adopts new laws, regulations and / or administrative
provisions substituting the previous laws, regulations and / or administrative provisions,
whether the previous names are changed or not; and

(iii) a Party incorporates the whole or relevant part of its applicable laws, regulations and / or
administrative provisions listed in Part B of this Sectoral Annex into other laws, regulations
and / or administrative provisions.

(d) In making amendments to the laws, regulations and administrative provisions specified in
Section III of this Sectoral Annex, the Parties should take account of the need to maintain
consistency with the relevant decisions and recommendations of the OECD.

37

3. With respect to paragraph 2 of Article 2 of this Agreement, each Party shall, as a result of
the acceptance of the confirmation of test facilities by the Competent Authorities of the other
Party, accept the data for a test item generated by the confirmed test facilities as equivalent to
the data generated by its own test facilities which are confirmed to be compliant with the
the equivalence of GLP compliance monitoring
principles of GLP, taking into account
programme of both Parties, which are consistent with the OECD Council Decision-
Recommendation of 2 October 1989 [C(89)87 (Final)] as amended by the OECD Council
Decision of 9 March 1995 [C (95) 8 (Final)], provided:

(a) a certificate or an alternative document on the GLP compliance status of the test facility
issued by the Competent Authority of that other Party, in accordance with the applicable laws,
regulations and administrative provisions of that other Party specified in Section III of Part B
of this Sectoral Annex, is attached to the data; and

(b) the testing for which the data is generated is covered by the principles of GLP in both
Parties pursuant to the applicable laws, regulations and administrative provisions of each
Party.

4. (a) The list of the confirmed facilities referred to in paragraph 3 and 6 of Article 8 of this
Agreement shall be provided in an appropriate agreed format and include the following
information:

(i) the name and address of the test facility;

(ii) the dates of verification or confirmation;

(iii) the GLP compliance status; and

(iv) the areas of expertise as listed in point 4 of the Appendix to Annex III of the OECD
Council Decision-Recommendation of 2 October 1989 [C (89) 87 (Final)].

(b) Each Party shall,
information on the confirmed facilities upon a reasoned request by that other Party.

to the extent possible, provide the other Party with additional

(c) Each Party shall transmit to the other Party, without delay, information on any withdrawal
of the certificate of a confirmed test facility if the facility has been found to be non-compliant
with the principles of GLP.

5. (a) Each Party may request the other Party, by indicating in writing a reasoned doubt on
whether a study was conducted in accordance with the principles of GLP, to conduct further
inspections or study audits on a confirmed test facility, in accordance with the applicable
laws, regulations and administrative provisions of that other Party.

(b) The requested Party shall inform the requesting Party of the results of the inspections or
study audits, or provide an explanation why such an inspection or study audit has not been
carried out.

(c) The requesting Party shall not be obliged to accept the data generated by the test facility
concerned from the date on which the request is made, until the results of the further
inspection or study audit conducted by the Competent Authority of the requested Party have
re-confirmed the compliance of the test facility with the principles of GLP.

(d) If, in exceptional cases, doubts persist, and the requesting Party can justify a specific
concern, that Party may contest the compliance of the test facility concerned in accordance
with the provisions of Article 7 of this Agreement.

38

PART B

SECTION I

THE APPLICABLE LAWS, REGULATIONS AND ADMINISTRATIVE
PROVISIONS STIPULATING THE COVERAGE OF CHEMICALS SUBJECT TO
TESTING IN ACCORDANCE WITH THE PRINCIPLES OF GLP

EUROPEAN COMMUNITY

JAPAN

Medicinal Products:

Pharmaceuticals:

1986

Council Directive 87/19/EEC of 22
amending Directive
December
75/318/EEC on the approximation of the
laws of the Member States relating to
analytical, pharmaco-toxicological and
in
clinical
the testing of proprietary
respect of
medicinal products
and amendments
thereto

standards

protocols

and

Commission Directive 91/507/EEC of 19
July 1991 modifying the Annex to
Council Directive 75/318/EEC on the
approximation of the laws of Member
States relating to analytical, pharmaco-
toxicological and clinical standards and
protocols in respect of the testing of
propietary medicinal
and
amendments thereto

products

Veterinary Medicinal Products:

1986

Council Directive 87/20/EEC of 22
amending Directive
December
81/852/EEC on the approximation of the
laws of the Member States relating to
and
analytical,
in
clinical
the testing of veterinary
respect of
medicinal products
and amendments
thereto

pharmacotoxicological
and

standards

protocols

Pharmaceutical Affairs Law (Law No.
145, 1960) and amendments thereto, which
is implemented by:

the Enforcement of

Ordinance of
the
Pharmaceutical Affairs Law (Ministerial
Ordinance of the Ministry of Health and
Welfare, No. 1, 1961) and amendments
thereto

Veterinary Drugs:

Pharmaceutical Affairs Law (Law No.
145, 1960) and amendments thereto, which
is implemented by:

Ordinance on the Control of Veterinary
the
(Ministerial Ordinance
Drugs
Minister of Agriculture, Forestry, No. 3,
1961) and amendments thereto

of

Agricultural Chemicals:

Agricultural Chemicals Regulation Law
(Law No. 82, 1948) and amendments
thereto

39

Commission Directive 92/18/EEC of 20
March 1992 modifying the Annex to
Council Directive 81/852/EEC on the
approximation of the laws of Member
analytical,
States
pharmacotoxicological
clinical
standards and protocols in respect of the
testing of veterinary medicinal products
and amendments thereto

relating

and

to

Plant Protection Products:

Council Directive 91/414/EEC of 15 July
1991 concerning the placing of plant
protection products on the market as last
by Commission Directive
amended
95/35/EC of
and
14
amendments thereto

1995

July

Biocides:

the European
Directive 98/8/EC of
Parliament and of the Council of 16
February 1998 concerning the placing of
biocidal products on the market and
amendments thereto

Feed additives:

Council Directive 87/153/EEC of 16.2.87
fixing guidelines for the assessment of
additives in animal nutrition as amended
by Commission Directive 94/40/EC of 22
July 1994, and amendments thereto

Feed additives:

Laws concerning Safety Assurance and
Quality Improvement of Feed (Law No.
35, 1953) and amendments thereto, which
is implemented by:

The Establishment of the Standards for
Evaluation of Feed Additives (Livestock
Industry Bureau and Fisheries Agency,
Ministry of Agriculture, Forestry and
Fisheries,
and
amendments thereto

4-Chiku-A-201,

1992)

New
Chemicals:

Chemicals

and

Designated

Law concerning the Examination and
Regulation
of
of Manufacture
Chemical Substances (Law No. 117, 1973)
and
is
implemented by:

thereto, which

amendments

etc.

of

Designated

Ordinance Prescribing Test Items Relating
to New Chemical Substances and Toxicity
Research
Chemical
Substances (Ministerial Ordinance of the
Prime Minister, the Minister of Health and
Welfare and the Minister of International
Trade and Industry, No. 1, 1974) and
amendments thereto

New and Existing Chemicals:

Chemicals generated in the workplace:

Council Directive 92/32/EEC of 30 April
the seventh time
1992 amending for
the
on
67/548/EEC
Directive
approximation of the laws, regulations
and administrative provisions relating to
the
and
labelling of dangerous substances and
amendments thereto

classification,

packaging

Industrial Safety and Health Law (Law
No. 57, 1972) and amendments thereto,
which is implemented by:

Ordinance on Industrial Safety and Health
(Ministerial Ordinance of the Ministry of
Labour, No. 32, 1972) and amendments
thereto

40

Council Directive 88/379/EEC of 7 June
1988 on the approximation of the laws,
regulations and administrative provisions
of the Member States relating to the
classification, packaging and labelling of
dangerous preparations and amendments
thereto

Council Regulation (EEC) No. 793/93 of
23 March 1993 on the evaluation and
control of the risks of existing substances
and amendments thereto

Food additives:

Council Directive 89/397/EEC of 14
June 1989 on the official control of
foodstuffs and amendments thereto

Council Directive 93/99/EEC of 29
October 1993 on the subject of additional
measures concerning the official control
of foodstuffs and amendments thereto

Cosmetics:

the

Council Directive 93/35/EEC of 14 June
sixth time
1993 amending for
the
on
76/768/EEC
Directive
approximation of the laws of the Member
States relating to cosmetic products and
amendments thereto

41

SECTION II

COMPETENT AUTHORITIES

EUROPEAN COMMUNITY

JAPAN

Competent Authorities of the European
Community are the following authorities
or authorities succeeding them

Competent Authorities of
following
succeeding them

authorities

Japan are the
authorities
or

Austria

For all:

Federal Ministry
Forestry, Environment
Management

for Agriculture,
and Water

Belgium

For all:

Institut Scientifique de la Santé Publique

Denmark

For industrial chemicals:

Danish Agency for Trade and Industry

For medicinal products:

Danish Medicines Agency

Finland:

For all:

National Product Control Agency for
Welfare and Health

France

For Pharmaceuticals:

Ministry of Health, Labour and Welfare

For Veterinary Drugs:

Ministry of Agriculture, Forestry and
Fisheries

For Agricultural Chemicals:

Ministry of Agriculture, Forestry and
Fisheries

For Feed Additives:

Ministry of Agriculture, Forestry and
Fisheries

For New Chemicals
Chemicals:

and Designated

Ministry of Health, Labour and Welfare

Ministry of Economy Trade and Industry

For Chemicals generated in the work place:

Ministry of Health, Labour and Welfare

For industrial chemicals, pesticides and
other
and
cosmetics:

than medicinal

products

Groupe
Chimiques

Interministériel des Produits

For
medicinal
veterinary medicinal

products

products)

(except
and

42

cosmetics:

Agence Française de Sécurité Sanitaire
des Produits de Santé

For veterinary medicinal products:

Agence Française de Sécurité Sanitaire
des Aliments

Agence
vétérinaire

nationale

du médicament

43

Germany

For all:

Federal Ministry
for Environment,
Nature Conservation and Nuclear Safety

Greece

For all:

General Chemical State Laboratory

Ireland

For all:

Irish Laboratory Accreditation Board
(ILAB)

Italy

For all:

Ministry of Health

Netherlands

For all:

Ministry of Health, Welfare and Sports

Inspectorate for Health Protection (GLP
Department)

Portugal

For industrial chemicals and pesticides:

Instituto Portugues da Qualidade IPQ

Ministerio da Industria e Comercio

For medicinal products and veterinary
medicinal products:

Instituto National de Farmacia e do
Medicamento

Spain

44

For medicinal products:

Agencia Española del Medicamento

- Subdirección General de Seguridad de
Medicamentos

For pesticides:

Ministerio de Agricultura, Pesca

y Alimentación

45

Sweden

For medicinal products, hygiene and
cosmetics products:

Läkemedelsverket

(Medical Products Agency)

For all other products:

Styrelsen för ackreditering och teknisk

(Swedish Board for Accreditation and
Conformity Assessment – SWEDAC)

United Kingdom

For all:

Department of Health

GLP Monitoring Authority

46

SECTION III

THE APPLICABLE LAWS, REGULATIONS AND ADMINISTRATIVE
PROVISIONS STIPULATING THE PRINCIPLES OF GLP, VERIFICATION AND
CONFIRMATION

EUROPEAN COMMUNITY

JAPAN

and

regulations

Council Directive 87/18/EEC of 18
December 1986 on the harmonisation of
administrative
laws,
provisions relating to the application of
the principles of good laboratory practice
and the verification of their applications
for tests on chemical substances as last
amended
by Commission Directive
1999/11/EC of 8 March 1999 and
amendments thereto

Council Directive 88/320/EEC of 9 June
1988 on the inspection and verification of
Good Laboratory Practice (GLP), as last
amended
by Commission Directive
1999/12/EC of 8 March 1999 and
amendments thereto

Pharmaceuticals:

Pharmaceutical Affairs Law (Law No.
145, 1960) and amendments thereto, which
is implemented by:

(a) Ordinance Prescribing Standards for
the Conduct of Non-clinical Laboratory
Studies on Safety of Drugs (Ministerial
Ordinance of the Ministry of Health and
Welfare, No. 21, 1997) and amendments
thereto;

the Product

(b) the Treatment of Materials Concerning
Non-clinical Laboratory Studies on Safety
of Drugs Which Should be Attached to the
Application for
(import)
Division,
(Evaluation
Approval
Pharmaceutical Affairs Bureau, Ministry
of Health and Welfare, Yakushin No. 253;
Safety Division, Pharmaceutical Affairs
Bureau, Ministry of Health and Welfare,
Yakuan No. 29, 1997) and amendments
thereto; and

(c) The Establishment of the Guidelines
for the Conduct of GLP On-site Inspection
(Evaluation Division,
Pharmaceutical
Affairs Bureau, Ministry of Health and
Welfare, Yakushin No.
254; Safety
Division, Pharmaceutical Affairs Bureau,
Ministry of Health and Welfare, Yakuan
No. 30, 1997) and amendments thereto

Veterinary Drugs:

Pharmaceutical Affairs Law (Law No.
145, 1960) and amendments thereto, which
is implemented by:

(a)Ordinance prescribing Standards for the
Conduct of Non-clinical Laboratoy Studies

47

on Safety of Veterinary Drugs (Ministerial
Ordinance of the Ministry of Agriculture,
Forestry and Fisheries, No. 74, 1997) and
amendments thereto; and

(b) Management of Pharmaceutical Affairs
Law (Livestock Industry Bureau, Ministry
of Agriculture, Forestry and Fisheries, 12-
Chiku-A-No. 729, 2000) and amendments
thereto

Agricultural Chemicals:

Agricultural Chemicals Regulation Law
(Law No. 82, 1948) and amendments
thereto, which is implemented by:

studies

Practice

The Good Laboratory
for
toxicological
on
agricultural
Production
(Agricultural
chemicals
Bureau, Ministry of Agriculture, Forestry,
and Fisheries, 11-Nosan- No. 6283, 1999)
and amendments thereto

48

Feed additives:

Laws concerning Safety Assurance and
Quality Improvement of Feed (Law No.
35, 1953) and amendments thereto, which
is implemented by:

(a) The Good Laboratory Practice on feed
additives (Livestock Industry Bureau and
Fisheries Agency, Ministry of Agriculture,
Forestry and Fisheries, 63-Chiku-A-No.
3039, 1988) and amendments thereto; and

(b) The Establishment of the Guidelines
for
the Inspection based on the Good
Laboratory Practice on Feed Additives
(Livestock Industry Bureau and Fisheries
Agency, Ministry of Agriculture, Forestry
and Fisheries, 1-Chiku-A-No. 3441, 1990)
and amendments thereto

New
Chemicals:

Chemicals

and

Designated

Law concerning the Examination and
of
of Manufacture
Regulation
Chemical Substances (Law No. 117, 1973)
and
is
implemented by:

thereto, which

amendments

etc.

and

Designated

Substances
of

(a) Standard Concerning Testing Facility
Provided in Article 4 of the Ordinance
Prescribing Test Items Relating to New
Toxicity
Chemical
Research
Chemical
Substances (Planning and Coordination
Agency,
Environmental
Bureau,
Kanpogyou No.
Pharmaceutical
Affairs Bureau, Ministry of Health and
229; Basic
Welfare, Yakuhatsu No.
of
Industries
International Trade
and Industry, 59
Kikyoku No. 85, 1984) and amendments
thereto; and

Ministry

Bureau,

39;

49

(b) Test Results Used as Criteria for
Determination at the Examination etc. of
New Chemical Substances (Environmental
Health Bureau, Ministry of Health and
Welfare, Eisei No. 39; Basic Industries
Bureau, Ministry of International Trade
and Industry, 63 Kikyoku No. 822, 1988)
and amendments thereto

Chemicals generated in the workplace:

Industrial Safety and Health Law (Law
No. 57, 1972) and amendments thereto,
which is implemented by:

(a) Public Notification of the Standard to
be Satisfied by the Test Facility etc. under
the Provision of Article 34-3 (2) of the
Ordinance on Industrial Safety and Health
(Notification of the Ministry of Labour,
No. 76, 1988) and amendments thereto;

(b) The Enforcement of the Ordinance to
amend a Part of
the Ordinance on
Industrial Safety and Health, Ordinance to
Amend a Part of the Ordinance on Safety
of Boiler and High Pressure Container, and
the Ordinance to Amend a Part of the
Ordinance on Preventing Organic Solvents
Hazard, etc. (Labour Standards Bureau,
Ministry of Labour, Kihatsu No. 602,
1988) and amendments thereto; and

the Guideline of
(c) Establishment of
Certification of Compliance with GLP
under the Industrial Safety and Health Law
(Labour
Regarding Test Facility,
Standards Bureau, Ministry of Labour,
Kihatsu No. 123, 1989) and amendments
thereto

etc.

50

SECTORAL ANNEX

ON

GOOD MANUFACTURING PRACTICE

(GMP)

FOR MEDICINAL PRODUCTS

51

1. This Sectoral Annex applies to:

PART A

(a) the confirmation of the compliance with GMP requirements of manufacturing facilities for
medicinal products to which the GMP requirements of both Parties are applied in accordance
with the laws, regulations and administrative provisions of each Party specified in Section I of
Part B of this Sectoral Annex; and

(b) the acceptance of the data generated by confirmed manufacturing facilities (the certificate
issued by confirmed manufacturing facilities in accordance with the provisions of Part A of
this Sectoral Annex).

2. For the purpose of this Sectoral Annex:

(a) The term "medicinal products" means drugs which are industrially manufactured for
human use as defined in the laws, regulations and administrative provisions of Japan specified
in Section I of Part B of this Sectoral Annex, and medicinal products and intermediate
products which are industrially manufactured for human use as defined in the laws,
regulations and administrative provisions of the European Community in Section I of Part B
of this Sectoral Annex.

The definition of medicinal products above may include medicinal products intended for
clinical trials, active ingredients, chemical and biological pharmaceuticals, immunologicals,
radiopharmaceuticals, stable medicinal products derived from human blood or human plasma
and, where appropriate, vitamins, minerals and herbal medicines.

(b) The term “criteria for confirmation” means the GMP requirements.

(c)The term "Good Manufacturing Practice (GMP)" means that part of quality assurance
which ensures that products are consistently produced and controlled in accordance with the
quality standards appropriate for their intended use and as required by the applicable
marketing authorisation or product specifications.
(d) The term "inspection" means an on-site evaluation of a manufacturing facility to
determine whether such manufacturing facility is operating in compliance with GMP
requirements including the requirements of the applicable marketing authorisation or product
specifications. Such inspection is conducted in accordance with laws, regulations and
administrative provisions specified in Section I of Part B of this Sectoral Annex carried out by
a Competent Authority listed in Section II of Part B of this Sectoral Annex, and may include
pre-marketing and post-marketing inspection.

(e) It is understood that the term "amendment" referred to in Part B of this Sectoral Annex
includes the following cases that:

(i) a Party entirely or partially changes its applicable laws, regulations and/or administrative
provisions listed in Part B of this Sectoral Annex, whether those names are changed or not;

(ii) a Party terminates its applicable laws, regulations and /or administrative provisions listed
in Part B of this Sectoral Annex and adopts new laws, regulations and / or administrative

52

provisions substituting the previous laws, regulations and / or administrative provisions,
whether the previous names are changed or not; and

(iii) a Party incorporates the whole or relevant part of its applicable laws, regulations and / or
administrative provisions listed in Part B of this Sectoral Annex into another laws, regulations
and/or administrative provisions.

3. This Agreement does not cover mutual recognition of batch release (Kentei) referred to in
Article 43 of the Pharmaceutical Affairs Law (Law No. 145, 1960) of Japan and batch release
referred to in Article 4 of Directive 89/342/EEC of 3 May 1989 and in Article 4 of Directive
89/381/EEC of 14 June 1989 of the European Community.

4. With respect to paragraph 2 of Article 2 of this Agreement, each Party shall, as a result of
the acceptance of confirmation of manufacturing facilities carried out by the Competent
Authorities of the other Party, accept, regarding the medicinal products for which its
marketing authorization has been issued or for which product specifications are applicable,
the certificate issued by the confirmed manufacturing facilities of the conformity of each
batch to the marketing authorization or product specifications and exempt the importers from
the testing of each batch,
in accordance with the laws, regulations and administrative
provisions of each Party specified in the Section I of Part B of this Sectoral Annex, taking into
account the equivalence of GMP requirements of both Parties, provided that:

(a) such certificate is issued by the confirmed manufacturing facilities on the results of a full
qualitative analysis, a quantitative analysis of all the active constituents and all the other tests
or checks;

(b) the certificate contains a statement that the product has been manufactured in conformity
with GMP requirements; and

(c) both Parties apply the equivalent GMP requirements to the products of which the
certificate is issued.

5. In the certificate issued by the confirmed manufacturing facilities and related to each batch
to be exported, as referred to in paragraph 4 above, it will be certified, through the testing
which is required for the manufacturing of medicinal products in accordance with the laws,
regulations and administrative provisions of each Party specified in Section II of Part B of this
Sectoral Annex, that each batch of medicinal products is manufactured as required by the
applicable marketing authorisation or product specifications of the importing Party.

6. A sub-committee of the Joint Committee will be established in particular to monitor the
progress of the preparatory work set out in paragraph 9 of this Sectoral Annex and the
operation of this Sectoral Annex. It will report to the Joint Committee.

7. (a) The Parties will exchange information on, in particular:

(i) GMP for specific products or classes of products;

(ii) new technical guidance or inspection procedures;

(iii) quality defect, batch recalls, counterfeiting and other problems concerning quality; and

(iv) any suspension or withdrawal of a manufacturing authorisation.

53

(b) The Parties will agree detailed alert procedures through the sub-committee of the Joint
Committee to fulfil specific objectives of this Sectoral Annex.

(c) Equivalence of GMP for specific products or classes of products will be coordinated
according to a procedure established by the sub-committee of the Joint Committee.

(d) Notwithstanding paragraph 6 of Article 8 of this Agreement, each Party shall provide the
other Party and the Joint Committee with a list of the confirmed manufacturing facilities at
the frequency to be decided by the Joint Committee.

(e) Each Party will, upon reasoned request by the other Party, provide a copy of the most
recent inspection report on a confirmed facility within 30 days from the date of the request. If
the requested Party conducts an additional inspection, that Party will provide a copy of the
report of such additional inspection to the requesting Party within 60 days from the date of the
request. If after the exchange of inspection reports there remains serious cause for concern on
whether a manufacturing facility in the other Party complies with GMP requirements, each
Party may request the other Party to conduct further inspections on that facility.

(f) The Competent Authority of a Party will, upon request by an exporter, importer or the
Competent Authority of the other Party, confirm that a manufacturing facility in its territory:

(i) is appropriately authorised to manufacture medicinal products in accordance with its laws,
regulations and administrative provisions specified in Section I of Part B of this Sectoral
Annex;

(ii) is regularly inspected by the Competent Authorities; and

(iii) complies with its GMP requirements that are recognised by both Parties as equivalent.

laws,

8. With regard to paragraph 2 of Article 5, the exporting Party shall, in accordance with its
applicable
inspect periodically the
manufacturing facilities in order to ensure that the facilities fulfil its GMP requirements set
out in the laws, regulations and administrative provisions of that Party specified in Section I
of Part B of this Sectoral Annex.

regulation and administrative provisions,

9. (a) Articles 2, 4, 5, 7 and sub-paragraph (a) of paragraph 2 of Article 10 relating to this
Sectoral Annex and the provisions of this Sectoral Annex other than paragraph 6 and sub-
paragraph (b) of paragraph 7 and this paragraph shall not be applied before the thirtieth day
after the date of exchange of diplomatic notes confirming each other that the preparatory work
is completed. Such exchange of diplomatic notes is expected to take place within 18 months
after the entry into force of this Agreement.

(b) Through the preparatory work, the Parties shall reconfirm the equivalence of GMP
requirements and their implementation through the Joint Committee. The Joint Committee
will decide the detailed procedures for implementing this Sectoral Annex.

54

PART B

SECTION I:

(cid:1)

THE APPLICABLE LAWS, REGULATIONS AND

ADMINISTRATIVE PROVISIONS STIPULATING MEDICINAL PRODUCTS,
GMP REQUIREMENTS FOR MEDICINAL PRODUCTS, VERIFICATION AND
CONFIRMATION

European Community

Japan

65/65/EEC of

Council Directive
26
January 1965 on the approximation of
provisions laid down by law, regulation or
administrative action relating to medicinal
products and amendments thereto

Council Directive 75/319/EEC of 20 May
1975 on the approximation of provisions
laid
or
law,
administrative action relating to medicinal
products and amendments thereto

regulation

down

by

Commission Directive 91/356/EEC of 13
June 1991 laying down the principles and
guidelines of good manufacturing practice
for medicinal products for human use and
amendments thereto

for

Council Regulation (EEC) No 2309/93 of
22 July 1993 laying down Community
authorisation and
procedures
the
supervision of medicinal products
for
human and veterinary use and establishing
a European Agency for the Evaluation of
Medicinal Products
amendments
thereto

and

The latest version of the 'Guide to Good
Manufacturing Practice', Volume 4 of The
rules governing medicinal products in the
European Union and amendments thereto.

Pharmaceutical Affairs Law (Law No.145,
1960) and amendments thereto

Enforcement Order of the Pharmaceutical
Affairs Law (Cabinet Order No. 11, 1961)
and amendments thereto

Medicinal Products Stipulated in Article 1-
2, Paragraph 1,
Item 7 and 8 of
Enforcement Order of the Pharmaceutical
Affairs Law and Designated by the
Minister for Health and Welfare Hereby
(Public Notification of the Ministry of
Health and Welfare, No.17, 1994) and
amendments thereto

Ordinance for Buildings and Facilities for
Pharmacies, etc.(Ministerial Ordinance of
the Ministry of Health and Welfare, No.2,
1961) and amendments thereto

Ordinance for Manufacturing Control and
for Drugs and Quasi
Quality Control
Drugs
the
(Ministerial Ordinance
Ministry of Health and Welfare, No.16,
1999) and amendments thereto

of

Ordinance for Imported Drugs and Quasi
Drugs Management and Quality Control
(Ministerial Ordinance of the Ministry of
Health and Welfare, No.62, 1999) and
amendments thereto

55

SECTION II: COMPETENT AUTHORITIES

European Community

Japan

Ministry of Health, Labour and Welfare or
an authority succeeding this ministry

Competent Authorities of the European
Community are the following authorities
of the Member States of the European
Community or authorities succeeding them

Belgium

Inspection Générale de la Pharmacie

Algemene Farmaceutische Inspectie

Denmark

Lagemiddelstyrelsen

Germany

Bundesgesundheitsministerium
Paul-Ehrlich Institut (biologicals only)

Greece

Ministry of Health and Welfare

National Drug Organisation (E.O.F.)

Spain

Ministerio de Sanidad y Consumo

General

de

Control

Subdirección
Farmacéutico

France

Agence du Médicament

Ireland

Irish Medicines Board

Italy

56

della
Ministero
Farmaci e Farmacovigilanza

Sanita Dipartimento

la

Pharmacie

et

des

Luxembourg

Division
de
Médicaments

Netherlands

De Minister
Welzijn,
Gezondheidszorg

en Sport

van Volksgezondheid,
Inspectie voor de

Austria

Bundesministerium für Arbeit, Gesundheit
und Soziales

Portugal
Instituto da Farmácia e do Medicamento -
INFARMED

Finland

Lääkelaitos/Läkemedelsverket
Agency for Medicines)

(National

Sweden

Läkemedelsverket
Agency)

(Medical

Products

United Kingdom

Medicines Control Agency

European Community

European Agency for the Evaluation of
Medicinal Products

57

FINAL ACT

The undersigned:

The representative of

The EUROPEAN COMMUNITY, hereinafter referred to as “the Community”,

of the one part, and

the representative of Japan,

of the other part,

meeting for the signature of the Agreement on Mutual Recognition between the European
Community and Japan, hereinafter referred to as the “Agreement”, have signed the following
texts:

the Agreement including its Sectoral Annexes relating to:

1. Telecommunications Terminal Equipment and Radio Equipment

2. Electrical Products

3. Good Laboratory Practice (GLP) for Chemicals

4. Good Manufacturing Practice (GMP) for Medicinal Products

The representative of the Community and the representative of Japan have made the Joint
Declarations and exchanges of letters listed below and annexed to this Final Act:

– Joint Declaration on future negotiations on the Mutual Recognition Agreement between

Japan and the European Community

– Joint Declaration on international guides or recommendations concerning the technical

competence of conformity assessment bodies (CABs)

– Joint Declaration on facilitating market access

– Exchange of letters concerning completeness of the Sectoral Annexes

– Exchange of letters on the preparatory work for the Sectoral Annex on GMP for Medicinal

Products and information exchange

– Exchange of letters on the use of languages

58

JOINT DECLARATIONS
CONCERNING THE AGREEMENT ON MUTUAL RECOGNITION BETWEEN
JAPAN AND THE EUROPEAN COMMUNITY

Upon the signing of the Agreement on Mutual Recognition between Japan and the European
Community the Government of Japan (GOJ) and the European Community (EC) state the
following with regard to the Agreement.

1.

2.

On future negotiations on the Mutual Recognition Agreement between Japan and the
EC

To build on this Agreement, the GOJ and the EC will commence the negotiations on
the further extension of the sectoral coverage of the Agreement two years from the
date that the Agreement enters into force. In particular, the GOJ and the EC express
their intention to commence negotiations on Medical Devices and on Pressure
Equipment within that period.

On international guides or recommendations concerning the technical competence of
Conformity Assessment Bodies (CABs)

The GOJ and the EC express their intention to consider the relevant guides or
recommendations issued by international standardisation bodies as an indication of
adequate technical competence of CABs with regard to the implementation of the
applicable requirements of both Parties under the Agreement.

3.

On facilitating market access

lies in
The GOJ and the EC recognise that the significance of the Agreement
promoting trade and facilitating effective market access between Japan and the EC
with regard to conformity assessment of products and confirmation of facilities
covered under the agreement.

59

EXCHANGE OF LETTERS

CONCERNING COMPLETENESS OF THE SECTORAL ANNEXES

The [European Commission][Government of Japan] confirms that the Sectoral Annexes
of the Agreement on Mutual Recognition between the European Community and Japan
contain all existing third party conformity assessment or compliance procedures relating to
requirements, products or data covered by those Sectoral Annexes.

60

EXCHANGE OF LETTERS ON THE PREPARATORY WORK FOR THE SECTORAL
ANNEX ON GMP FOR MEDICINAL PRODUCTS AND INFORMATION EXCHANGE

The [European Community][GOJ] underlines its commitment

to a thorough and
speedy implementation of the preparatory work required by paragraph 9 of the Sectoral
Annex on GMP for Medicinal Products. It will be guided in its task by the needs to set out the
phases of preparatory work, and the components of a GMP compliance and two-way alert
programmes against which reconfirmation of equivalence will take place taking into account
the previous experiences.

The [EC][GOJ] will organise an exchange of information, including at least one
inter alia, cover the criteria for designation and the criteria for

seminar which would,
confirmation in the coming months.

61

EXCHANGE OF LETTERS ON THE USE OF LANGUAGES

The [European Community][GOJ] will in exchanging information,

including, for
example, GMP inspection reports, under the Agreement use their own languages with a
summary in English unless otherwise agreed. It is appropriate that the Joint Committee looks
into this matter at an early opportunity.

62

RECORD OF DISCUSSION

In connection with the negotiations on the Agreement on Mutual Recognition between Japan
and the European Community, signed at []today (hereinafter referred to as the “Agreement”),
the undersigned hereby wish to record the following:

1.
It is confirmed that the term “administrative provisions” referred to in the Agreement
means measures taken by the relevant administrative authority(ies) to implement any relevant
laws and regulations.

2.
It is confirmed by the European Community that international agreements which it has
concluded are directly applicable by it in its territory and binding upon its institutions and
Member States.

For Japan:

For the European Community:

63

FINANCIAL Statement 2001-2005

External trade relations – Mutual Recognition Agreement

1. TITLE

External Trade Relations-

Mutual Recognition Agreements with Japan.

2. BUDGETARY HEADINGS:

B7-8500

A-7010

3. LEGAL BASIS

• Article 133 of the Treaty of Rome

• Proposal for Council decisions N° .... on the implementation by the European Community
of a mutual recognition agreement with Japan.

4. DESCRIPTION OF OPERATION :

4.1 General objective:

The purpose of this agreement
is to establish mutual recognition of certification of
conformity of products with technical regulations or standards of the partner to the
agreement.

The major actions which will be pursued by the Commission under this budget line will be
the following:

• Confidence-building activities

to facilitate the proper

implementation of

the

Agreement.

• Management of the Agreements and maintenance of

the necessary degree of

confidence.

The Commission will be assisted by experts, particularly in regard to sectoral activities. It
will however remain the final arbiter in the management of these agreements.

4.2 Duration of the action; means foreseen for its renewal:

The general action undertaken will be of an indefinite duration. The initial period of
confidence-building required by the Agreement will require a more intensive effort and
expenditure, but this should be substantially less after 2 years. However, during the life of
the Agreements a continued effort will be needed to ensure management and maintenance
of confidence.

64

5. CLASSIFICATION OF EXPENDITURE/REVENUE

5.1 Non-compulsory expenditure ("DNO")

5.2 Differentiated appropriation ("CD")

5.3 Type of revenue involved:

None

6. TYPE OF EXPENDITURE/REVENUE

-

-

100% subsidy: No

subsidy for co-financing with other sources in the public or private sector?

Yes, this may be envisaged as a method of funding. Subsidies will be awarded according to
the Commission’s “Vademecum on Grant Management”. Grants may be provided to
professional associations and other responsible organisations for activities related to the
implementation of the Agreement.

-

-

Interest subsidy: No

Others

Financing of events, acquisition of studies, publications and conferences.

Should the action prove an economic success, is there provision for all, or part

-
of, the Community contribution to be reimbursed?

Not relevant

-

Will the proposed operation cause any changes in the level of revenue?

No

7. FINANCIAL IMPACT ON APPROPRIATIONS FOR OPERATIONS

7.1

Method of calculating the total cost of the operation:

The estimation of costs is based on the anticipated requirements in terms of expenses
related to training, seminars, workshops, travel of experts, verification of conformity
assessment bodies, information and studies. The total estimated cost is based on the sum of
the individual actions.

A range of different actions are foreseen to meet the objectives of the budget-line and costs
will vary depending on the nature of action undertaken. Even for similar types of action
(e.g. seminars) costs will vary depending on the scope of the action and the degree of
specialisation needed.

The costs of specific actions will be determined either:

65

•

•

•

by the Commission when it organises activities itself, e.g. seminars

following invitations to tender issued by the Commission

following requests for subsidies. In such cases, projects are selected according to how
well they meet the criteria which have been established for selection. Subsidies will be
awarded according to the rules of the “Vademecum on Grant Management”.

A. Attendance at Joint Committee

These will be attended by Commission officials and some experts from the Member
States. Travel and per diem expenses should be foreseen within the normal range of such
expenses. The travel expenditure for officials will be covered by the “Mission budget”
(A-7010). The reimbursement of travel and related expenses for experts will be made on
line B7-8500.

B. Attendance at Joint Sectoral Groups

These will also be attended by Commission officials and given the nature of these
meetings a larger contingent of experts from the Member States. Travel and per diem
expenses should be foreseen within the normal range of such expenses. The travel
expenditure for officials will be covered by the “Mission budget” (A-7010). The
reimbursement of travel and related expenses for experts will be made on line B7-8500.

C. Workshops and Seminars

These will be held to familiarise economic and other operators with the requirements of
the Agreement. The cost of these seminars will vary according to the subject matter and
location, and will include organisational costs (when in Europe) and substantial travel
costs when in the territory of the partner country. Organisational costs in Europe will cost
c. 3000 Euro each. The number of seminars will vary depending on the individual
industrial sectors covered by the Agreement.

D. Verification actions

The competence of the conformity assessment bodies (CABs) will in many cases have to
be checked, more so in the initial period of the Agreement, but as a matter of course
throughout the life of the Agreement to maintain confidence in the system.

This will involve on-site assessment by teams of experts of conformity assessment bodies
in the partner country in the initial stages, and subsequently investigation of complaints.
This expenditure will be essential in all sectors of the Agreement (4 in number) and may
involve numerous CABs in each sector including at subfederal or local level in certain
cases.

E. Production and dissemination of information

Certain costs may need to be incurred for the dissemination of information. Guides to
regulations and assessment procedures may be needed typically at a cost of 10 000 Euro.

7.2

Breakdown by elements of the operation

“Trade Agreements with important Trading Partners”

66

For 2001, this involves the following calculation:

Budget Heading

Amounts
(Euro)

Method of calculation

No. of missions

Standard Unit cost

Japan: Travel: 3 000
Euro; per diem: 260 Euro

360
London:
Euro; per diem: 199 Euro

Travel:

Brussels: Travel:
800
Euro; per diem: 150 Euro

Joint Committee3

8 660 Bxl

B7-8500

Japan

Joint
Committee3

Sub-

37 896 London
8

B7-8500

Seminars

B7-8500

Japan

19 520 Japan

Bxl

Verifications

18 900 Japan

1

2

8

4

4

5

B7-8500

Information

B7-8500

10 000

B7-8500: Total

94 976

32

In Euro

(current prices)

Breakdown

Year

2001

Year

2002

2003

2004

2005

Total

2001-2005

3

These will be attended by Commission officials and some experts from the Member States.

67

A. Joint Committee

8.660

8 660

8 660

1 250

7 560

34 790

B. Joint Sub-Committee

37 896

37 896

9 474

9 474

9 474

104 214

C. Seminars

19 520

19 520

39 040

D. Verifications

18 900

18 900

8 600

8 600

8 600

63 600

E. Information

10 000

10 000

10 000

30 000

Total

94 976

94 976

36 734

19 324

25 634

271 644

7.3

Indication of the timetable for commitment and payment appropriations

Year

2001

2002

2003

2004

2005

1000 Euro

Total

2006

and
following
years

Schedule
Commitment

of

95

95

37

19

25

271

Payment
appropriations

2001

2002

2003

2004

2005

2006

95

95

37

19

25

95

95

37

19

25

Total

95

95

37

19

25

271

68

8.

WHAT ANTI-FRAUD MEASURES ARE PLANNED IN THE PROPOSAL
FOR THE OPERATION ?

Methods of control (submission of reports, etc.) will be included in all contracts between
the Commission and beneficiaries.

A close cooperation with the delegations of the Commission and the participation of a
representative of the Commission at events in third countries will check on the spot the
work to ensure that it corresponds with the terms of reference, contract provisions and
required professionalism.

The checks take place before the final payment. The same rule applies to the financial
incentives paid to participating companies. Where appropriate, agreements also require
organisations to submit financial accounts certified by their auditors.

In those cases involving cooperation with EU industrial federations the accounts are
further checked at the Annual General Meeting of the federations concerned.

9.

ELEMENTS OF COST-EFFECTIVENESS ANALYSIS

9.1.

Specific objectives of the proposed operation, population targeted

-

The specific objectives of mutual recognition agreements are:

•

•

•

to avoid duplication of certification by economic operators.

to promote exports, employment, competitivity and investment.

to reduce costs, in particular for small and medium-sized enterprises and ultimately for
the consumer.

-

Target population

The target population are the exporting companies, business associations, chambers of
commerce and public institutions of the European Union and the general consumer which
will benefit, or have an interest in, the mutual recognition of certification.

9.2.

Reasons for the operation

-

Need for intervention from the Community budget

Under Article 133 of the Treaty of Rome the Community has exclusive competence for
commercial policy and these agreements have been negotiated in accordance with a
mandate of the Council of Ministers and in consultation with the 133 Committee. The
Commission will be responsible for implementation and management of the agreement.

-

Choice of methods of intervention

* advantages over alternative measures (comparative advantages)

* analysis of similar operations at Community or national level

* results and expected multipliers

69

The choice of management method (Joint Committee and a Joint Sub-Committee) have been
set out in the Agreement and constitutes a minimum necessary for the proper functioning of
the Agreement. The use of seminars in the initial phases to ensure familiarity with other
systems will also be a necessary part of the confidence building.

These seminars and verifications are also designed to build mutual confidence; verifications
will also be required to ensure this confidence is maintained throughout the life of the
agreement. Confidence and its maintenance are keys to the successful operation of the
agreement.

The importance of this budget is justified when put in perspective with the trade involved in
these agreements and the yearly savings for EU exporters which are expected (estimated on a
yearly basis at 70 millions Euro for EU exporters to Japan).

Main factors of uncertainty which could affect the specific results of the

-
operation.

* None

9.3

Monitoring and evaluation of the operation

-

Performance indicators selected

* Output indicators

* indicators of impact, following the objectives chosen

In the case of these Agreements, success can be quantified by trade facilitation through
avoidance of duplication of testing and certification and costs. Yearly estimated savings for
the European Community are indicated above (9.2).

Success can also be measured by increased EU exports and this factor will be taken into
consideration although export performance is subject to such a wide range of variables
(e.g. changes in exchange rates) that this can never be the sole factor for evaluation.

-

Evaluation of results

Progress in the attainment of the Agreements objectives will be monitored by Commission
officials, the Joint Committee established under the Agreement and by the economic
operators concerned.

-

Details and frequency of the planned evaluation

The evaluation of the effectiveness and usefulness of the agreements will be regularly
monitored by the Commission and by the Joint Committee established under the agreement at
annual meetings.

10. ADMINISTRATIVE EXPENSES

Human resources and administrative means are to be covered by the credits already allocated
to the managing service. There is no request for additional staff.

70

10.1

Effect on the number of posts

Type of post

Staff to be assigned to
managing the operation

Source

Duration

Permanent
posts

Temporary
posts

DG I
+
sectoral DGs

Additional
resources

Existing
resources in the
or
DGs
departments
concerned

Officials

A

3.5

None

3.5

None

permanent

B

C

Other resources None

Total

1

4.5

1

4.5

10.2

10.3

Overall financial impact of human resources: 4.5 staff (107 500 Euro per staff
member per year = 483 750 Euro).

Increase in other administrative expenditure as a result of the operation (A-
7010: travel expenses)

The expenses set out below relate to travel expenses for officials of the Commission attending
meetings of the Joint Committee, the Joint Sub-Committee, seminars and verifications, when
these are outside Brussels. These will be taken care of by the relevant budget allocations of
various Directorates Generals involved.

For 2001 this involves the following calculation:

Budget heading

Amounts (Euro)

Method of calculation

No. of missions

Standard Unit cost

71

Joint Committee

Japan

2

Japan: Travel: 3 000
Euro; per diem: 260 Euro

A-7010

Joint
Committee

Sub-

A-7010

Seminars

A-7010

Verifications

A-7010

A-7010: Total

7 560

7 560

15 120

11 340

41 580

Japan

2

Japan

Japan

4

3

11

In Euro

Total

2003

2004

2005

2001-2005

Year

2001

Year

2002

A.
Committee

Joint

B Joint Sub-
Committee

C. Seminars

D.
Verifications

7 560

7 560

7 560

7 560

7 560

37 800

7 560

7 560

7 560

7 560

7 560

37 800

15 120

15 120

30 240

11 340

11 340

11 340

11 340

11 340

56 700

TOTAL

41 580

41 580

26 460

26 460

26 460

162 540

72

IMPACT ASSESSMENT FORM

THE IMPACT OF THE PROPOSAL ON BUSINESS WITH SPECIAL REFERENCE
TO SMALL AND MEDIUM-SIZED ENTERPRISES( SMEs)

Title of proposal

Proposal for a Council Decision on the conclusion of an Agreement between the European
Community and Japan on Mutual Recognition in relation to Conformity Assessment.

Reference number

The proposal

The legislation is necessary to conclude an Agreement between the European Community and
Japan on Mutual Recognition in relation to Conformity Assessment, Certificates and
Markings. This is an agreement negotiated and initialled by the Commission in accordance
with the mandate and negotiating directives provided by the Council on 21/9/92.

The impact on business

The business sectors affected are telecommunications terminal equipment, electrical
equipment, medicinal products, and industrial chemicals.

The Agreement permits certification of conformity with technical regulations on product
safety, etc, to be conducted in Europe for exports destined for Japan. This avoids the necessity
for further certification by Japanese conformity assessment bodies before putting them on the
Japanese market.

therefore presents important advantages from the point of view of
The Agreement
transparency, market access, avoidance of duplication especially of cost and general
facilitation of trade. This is of particular importance for small and medium-sized enterprises.

The Agreement covers a wide range of sectors spread throughout the Community and an
extensive range of firms in these sectors both large and small. the advantages are not limited
to specific geographical areas in the Community.

Businesses will have to comply with Japanese regulations and procedures, but
the
certification, as stated above, will be conducted by conformity assessment bodies located in
the Community and designated by the Member States, and not in Japan.

The Agreement will substantially reduce certification costs and improve prospects for exports,
employment, investment and competitiveness by European firms.

The Agreement does not contain measures to take account of the specific situation of small
and medium-sized firms, but by its nature and by reducing certification costs which are the
same for all firms, the agreement will benefit small and medium sized enterprises to a greater
extent proportionately than larger firms.

Consultation

73

The main trade organisations in each sector eg Eurobit, Orgalime, EFPIA, have been
consulted and have universally declared their support for the Agreement.

74

EU TRADE WITH JAPAN (M Euro)

EXPORTS

IMPORTS

Products

Products

Industrial Chemicals

2 066

Industrial Chemicals

1 958

Pharmaceuticals

2 030

Pharmaceuticals

784

Electrical Equipment

1 956

Electrical Equipment

10 042

Telecommunications
Terminal Equipment

1 022

Telecommunications
Terminal Equipment

1 500

75