Recommendationsof theEU-Japan Business Round Table
to the Leaders of the European Union and Japan
Brussels, 4 November 2021

Working Party 2
Life Sciences and Biotechnologies,
Healthcare and Well-being

Working Party Leaders:Dr. Thomas-Peter Hausner
President, Representative
Director & Senior Bayer
Representative for Japan
Bayer Holding Ltd.

Mr. Osamu Nagayama
Honorary Chairman
Chugai PharmaceuticalCo., Ltd.

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List of Abbreviations
Abbreviation
BRT
CAS
CEA
CGP
EIR
EPA
EU
EUA
GCP
GMO
GMP
GOJ
HTA
ICER
IP
ISHL
ISO
J-PMD Act
MDD
MDR
MDSAP
METI
MHLW
MRA
NHI
PBT/vPvB
PDSCL
PHR
PMDA
PMP
PRTR
QALY
QMS
R&D
REACH
RMP
SME
UK
WP

Meaning
EU-Japan Business Round Table
Chemical Abstracts Service
Cost Effectiveness Analysis
Comprehensive Genomic Profiling
Environment Impact Reduction
Economic Partnership Agreement
European Union
Emergency Use Authorisation
Good Clinical Practice
Genetically Modified Organism
Good Manufacturing Practice
Government of Japan
Health Technology Assessment
Incremental Cost Effectiveness Ratio
Intellectual Property
Industrial Safety and Health Law
International Organization for Standardization
Japanese Pharmaceutical and Medical Device Act
Medical Device Directive
Medical Device Regulation
Medical Device Single Audit Program Pilot
Ministry of Economy, Trade and Industry
Ministry of Health Labor and Welfare
Mutual Recognition Agreement
National Health Insurance
Persistent, Bioaccumulative and Toxic / very Persistent and very
Bioaccumulative
Poisonous and Deleterious Substance Control Law
Personal Health Records
Pharmaceutical and Medical Device Agency
Price Maintenance Premium
Pollutant Release and Transfer Register
Quality-adjusted life years
Quality Management System
Research & Development
Registration, Evaluation, Authorization, Restriction and Chemicals
Risk Management Plan
Small and medium-sized enterprise
United Kingdom
Working Party

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Introduction
Japan and the EU face many similar challenges, such as aging populations,shifting demands for products and services, and rising costs in many aspects of
the welfare system. In addition, the crisis caused by COVID-19 profoundly
affected every part of society and has underlined the importance of science andtechnology. Life sciences and biotechnologies offer the possibility oftechnologies that will help address these challenges.
Working Party 2 focuses on the following sectors:• Healthcare (pharmaceuticals and medical devices)• Life Science & Industrial Chemicals• Plant Protection & Biotechnology• Animal Health
The recommendations of WP-2 have the clear aim to improve the innovation
capabilities of both the EU and Japan through concrete action plans in life
sciences and biotechnology. The focus is on measures that will enhance efficient
healthcare practices, food technology and supply, and biotechnology.
The EU-Japan Business Round Table (BRT) welcomes the recent publication of
the Pharmaceutical Industry Vision 2021 by the Ministry of Health, Labour andWelfare (MHLW) in Japan, in which it emphasizes the importance of continuous
innovation to protect people’s health and lives and thereby the need to promote
pharmaceutical industry policy. The BRT especially appreciates that the Vision
clearly states the need to ensure the predictability of the market and enable
companies to expect appropriate rewards for their investments in Japan. The
BRT expects public-private collaboration will be further enhanced to realize the
Vision and improve the drug discovery and research and development systems
as well as the international harmonization of regulations to achieve an innovationconducive environment.
The conclusion of the Economic Partnership Agreement (EPA) was a majorachievement for both sides and will bring mutual economic benefit.
Instead of an ending, the EPA should be seen as a beginning. It should be alaunch pad: a chance to renew our commitment to removing barriers to business;a chance to find new energy for strengthening our economic relationship; achance to deliver on the recommendations in this report. Let us take thosechances.
An asterisk (*) identifies “priority” recommendations.

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Recommendations from both
European and Japanese industries
COVID-19
WP-2 / # 01 / EJ to EJ
Regulatory environment should be improved for COVID-19 and infectious
disease control
The BRT calls on the EU and Japanese Authorities to:•••support the research, development, and manufacturing of diagnosis,
treatments and vaccines for COVID-19 and coordinately promotecollaborative actions of companies and/or academia to accelerate theirdevelopments, provide appropriate and prompt compensation and protection
scheme for those treated and providing treatments,
address the inequity in the access to COVID-19 vaccines in collaboration withindustry and non-governmental organizations by removing barriers hindering
the equity, andcontinuously promote the research and development for other infectious
diseases especially for AMR (Antimicrobial Resistance).

The BRT believes that:•••collaborations among government, industry and academia have madeCOVID-19 vaccines available at an unprecedented speed. Continued support
is needed to promote the scale up of the vaccine production and thedevelopment of therapeutics and to ensure people are inoculated and treatedfairly. Though all the COVID-19 vaccines and therapeutics undergo rigorousstudies on safety and efficacy, health damage may possibly occur with themin some cases. Speedy, accessible, and effective compensation should be
provided to those suffering health damage resulting from vaccinations anddischarge all parties involved in the provision of COVID-19 vaccines andtherapeutics from civil liability to facilitate and protect the healthcare provision
for COVID-19,
COVID-19 vaccines are not equally reaching all populations worldwide. Traderestrictions and regulatory barriers should be removed to facilitate the crossborder supply of COVID-19 vaccines and materials needed to manufacture
the vaccines in order to maximize the production and improve the vaccine
equity, andovercoming the pandemic is the most important issue, but there are alsosignificant challenges in the medium to long term. The number of drugresistant bacteria is increasing, and if this situation continues, it is predictedthat the annual number of deaths worldwide by 2050 due to drug-resistantbacterial infections will rise to approximately 10 million. At the same time, it isnecessary to secure resources for solving such problems. Support for theWorking Party 2: Life Sciences and Biotechnologies, Healthcare and Well-being
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development of new anti-infectives, including support for small and medium sized enterprises (SMEs) which play a critical role in developing innovative
new medicines, are vital. The BRT welcomes the governments’ recognitionof the need to foster SMEs. Building on some measures taken in response to
the COVID-19 pandemic, further enhancing public support is a way forward
to help hedge the risk of the research and development for emerging AMR
and other infectious diseases.

HEALTHCARE
WP-2 / # 02 / EJ to EJ
Mutual recognition should be improved for Medical Devices
Mutual recognition of quality management audit results for Medical
Devices should be established between EU and Japan.
The BRT calls on the EU and Japanese Authorities to:
•

•
•
•
•
•

introduce a mutual recognition scheme for Quality Management System(QMS) audit results, preferably through EU accession to the Medical Device
Single Audit Program Pilot, or through regulatory harmonization between the
EU and Japan,
harmonize submission-related formats and standards,
ensure post-approval QMS inspection dates coincide with the renewal ofmarketing authorization rather than every 5 years in order to simplify andassure proper renewal operation,
introduce mutual recognition of Medical Devices products for lower risk
classes as soon as possible,
harmonize the introduction schedule for new ISO standards, including a grace
period, thereby ensuring they apply the same revision of a particular ISO
standard, andaddress issues above through the next revision of the J-PMD Act.

The BRT believes that:•

the QMS inspection process remains complicated and burdensome despite
Japan now accepting the ISO13485 audit report under the 2014 J-PMD Act.

There should be mutual recognition of Medical Devices product licenses.
The BRT calls on the EU and Japanese Authorities to:•mutually recognize Medical Devices product licenses. Existing similarities
between EU and Japanese regulations on low-risk class II devices makemutual recognition on product licenses for this category of products possible.
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The BRT calls on the Japanese Authorities to:•ensure PMDA and MHLW introduce mutual recognition, taking into accountthe difference of classification of medical devices between Japan and the EU.

The BRT calls on the EU Authorities to:••

improve their communication with the Government of Japan (GOJ) in relation
to the new Medical Device Regulation (MDR) implementation, andmonitor whether the switch from the Medical Device Directive to MDR does
indeed accelerate the mutual recognition of clinical trials results in Japan.

The BRT believes that:••

harmonizing QMS and classification should allow new products to be
introduced in both the EU and Japan within the same time frame and in one
process, andthe EU Authorities are communicating insufficient information to Japan about
the MDR.

There should be mutual recognition of clinical trial results for Medical
Devices.
The BRT calls on the Japanese Authorities to:•••accelerate mutual recognition of clinical trial results in actual operation, where
the conformity is currently insufficient due to the existing strict conditions
applied when accepting clinical evaluation reports originating outside ofJapan,
provide early disclosure of a clear guidance for judgment on the need forclinical studies, conditions for acceptance, etc. in order to make the actual
operation of GCP smoother, anddevelop guidelines for effective utilization of clinical evaluation reports assoon as possible. The EU industry side requests that the GOJ responds withspecific timelines for this action as this has been a previously listed request
with no practical progress.

The BRT believes that:••

although foreign clinical trial data can be accepted in Japan as part of theapplication dossier under specific circumstances, additional datarequirements were sometimes imposed on manufacturers without providing
the rational regarding such request,
the acceleration of mutual recognition of clinical trial results for thedevelopment of new Medical Devices would ensure access to new products
for patients in Japan and the EU, both within the same timeframe and throughone process. This would allow for further reducing the device lag, ensuring a

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•high level of quality whilst minimizing the administrative burden on
manufacturers, andearly disclosure of clinical trial-related guidance would promote the entry ofoverseas companies to the Japanese market.

PLANT PROTECTION & BIOTECHNOLOGY
WP-2 / # 03 / EJ to EJ
Legal clarity for and appropriate regulation of Plant Protection innovation,
including genetically-modified plants and gene-edited plants
The BRT calls on the EU and Japanese Authorities to:• regulate agricultural technologies, including crop protection, geneticallymodified and gene-edited crops in a science-based and proportionate manner,• advance and adhere to global harmonization of genetically-modified
organisms’ risk assessments, and support the Global Low Level Presence
Initiative,• provide legal clarity on the status of techniques such as genome editing andcorresponding labelling requirements (e.g. for genome-edited derived food),• work with industry and other stakeholders to increase trust in the regulatory
science and gain greater societal acceptance, and• work with stakeholders to promote emerging technologies for sustainable andprecision food production enabling environmental impact reduction fromagricultural production.
The BRT believes that:• a fact-based platform for dialogue and sharing of information as well as a riskproportionate, predictable, science-based treatment of new technologies isrequired,• taking a science-based and proportionate regulatory approach to agricultural
technologies will aid gaining societal acceptance and help weeding out
misinformation,• ongoing regulations regarding data requirements for emerging technologies
are not fully updated resulting in duplication of studies, and• incentive to growers is necessary to promote new technologies for theenvironmental impact reduction (EIR) to enable growers to benefit from EIR
initiatives.

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HEALTHCARE
WP-2 / # 04* / EJ to J
Reform of the pharmaceutical pricing system should provide a stable,
predictable environment that rewards innovation
The BRT calls on Japanese Authorities to:
•

•

•
•

•

•

•
•

under the MHLW’s Pharmaceutical Industry Vision 2021, continuously review
the current pricing system to strengthen the reward for innovation, maintainan incentive for companies to develop new drugs, and to bring them rapidly
to meet patients’ needs in Japan,
limit the scope of off-cycle price revisions. Since drug expenditure has been
well controlled by the current pricing system, the scope of off-cycle pricerevisions must be limited to exceptional cases, such as the marketed price issignificantly lower than the listed price. Innovative patented products should
not be subject to off-cycle price cuts,
expand the Price Maintenance Premium (PMP) system to cover all innovative
products, incl. incremental innovations during their patent exclusivity periodwith the next drug pricing system reform in April 2022,
further revisit corporate indicators as basis for PMP eligibility; corporate
indicators measure the ranking of companies, but are currently unpredictableand do not reflect the degree of innovativeness of individual products,
including the tangible benefits provided to the patients,
expand the reward for innovation for launching an innovative additional
indication after initial NHI listing and recognizing real clinical and patient
benefit so that it includes real world evidence as well as scientifically-validated
patient reported outcomes,in the mid-term, improve the PMP system such as to reflect broader range ofvalues each product provides beyond its price to decide on PMP eligibility,e.g., patient’s and healthcare provider’s benefit, social contributions inaddition to clinical improvements,
expand the scope of pricing policy reforms beyond drug costs, as drug costs
are only one part of the overall healthcare costs, andincrease opportunities and time for constructive and meaningful dialogues
between the authorities and industry to allow the industry to provide input andensure transparency of policy decisions.

The BRT believes that:•the administrative labour and costs involved in drug price surveys and drug
price revisions, which are required to implement annual revisions are aconsiderable cost driver and in consequence hinder a sustainable reduction
in medical costs. Therefore, in order to improve the return on investment andpolicy implications of the off-cycle price revision, it is necessary to limit therevision’s scope,

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•

•

•

•

•
•

•

the repeated revisions to the pharmaceutical pricing system introduced since
2018 with as short as three-month notice, including the off-cycle price revisionin 2021, created significant issues with business predictability for theJapanese market and could result in a delayed access to the latest treatments
for Japanese patients. Market predictability is essential as the developmentof innovative drugs requires long-term and substantial investment,
MHLW’s Pharmaceutical Industry Vision 2021, officially announced in
September 2021, should be leveraged to encourage industry to generateinnovations in Japan. Unless innovation is properly evaluated, it becomesincreasingly challenging for industry to continuously create innovative drugs
to fulfil unmet medical needs. This will not be beneficial to patients nor tosociety,in April 2020, minor changes were made to product requirements andcompany indicators for PMP; as for the product requirements change, theBRT welcomes that products will be eligible for PMP if their additional
indications are recognized to be innovative or useful,company indicators are evaluation criteria based on past company records
and are not directly related to the innovative value of individual products andsuch products or companies’ future contribution to the healthcare system andpatients’ benefits. It is necessary to verify the effects of this system and tocontinually review the system,
expanding the reward for innovative additional indications leads to further
access to innovative treatments and additional benefits for patients,
drug costs are only one part of the overall healthcare costs: a holistic view isneeded, and a fundamental reform should not be limited to managing drug
prices only. Thus, to ensure long term healthcare system sustainability while
securing reward for innovation, future reforms should include a review of allhealthcare costs and revenue sources, including medical fees, medical
procedures, hospital stays, patient co-payments etc., andopportunities for the industry to provide input on healthcare and pricing reformare currently limited, with which meaningful discussions cannot be made.
Opportunities should be enhanced for more constructive dialogues andworking level discussions.

WP-2 / # 05 / EJ to J
The 14-day prescription restriction rule for new pharmaceuticals should be
abolished
The BRT calls on the Japanese Authorities to:•abolish the 14-day prescription restriction rule.

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The BRT believes that:••the 14-day rule is no longer required because the safety of new drugs inJapan is now underpinned by the post marketing surveillance system and theintroduction of a Risk Management Plan (RMP), andwith the wider adoption of telemedicine, medical consultations are no longer
limited to face-to-face and frequent consultations can be achieved without
relying on the 14-day rule. The restriction is now an unnecessary regulation,
only hindering patient access to and benefit from new medicines.

WP-2 / # 06 / EJ to J
The environment for innovative Medical Devices should be improved in
Japan
Japan should further sub-divide the current functional classification for
Medical Devices
The BRT calls on the Japanese Authorities to:•••revise the reimbursement pricing scheme bringing it closer to a productoriented system,
improve the reward for innovation by sub-dividing current functionalclassifications, andset the reimbursement price for old products separately from thereimbursement price for new products.

The BRT believes that:•

it would be sensible to allow a certain period-of-time prior to conclusive
assessment because it often takes time for effectiveness of new products tobecome apparent and safety and efficacy to be adequately addressed.

Health insurance environment for cancer genome profiling (CGP) testingshould be improved for patients to get early access to indicated testing
The BRT calls on the Japanese Authorities to:•enable patients to conduct CGP testing and receive their results at optimal
timings using public insurance system.

The BRT believes that:•

CGP testing which comprehensively detects cancer-related genes has been
covered by national health insurance and reimbursed as a medical device
since June 2019, but there is a restriction that they are reimbursed only if
CGP testing are performed at the end of the standard of care when patients

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already get drug resistance or are in worse general status. An environment issocially demanded where each patient can get access to CGP testing at early
and optimal timings.

WP-2 / # 07* / EJ to J
Careful application of Health Technology Assessment (HTA)
Health Technology Assessment (HTA) for Pharmaceuticals should not
become a barrier for patient access
The BRT calls on the Japanese Authorities to:••

keep refining the system of using HTA and Cost Effectiveness Analysis (CEA)
for Pharmaceuticals, andrefrain from using CEA in making reimbursement decisions.

The BRT believes that:
•

•

•

•
•

use of CEA for reimbursement decisions would possibly lead to a recurrenceof drug lag and fully agrees with the government’s decision not to use CEA todecide reimbursement. CEA/HTA should be positioned as being
supplemental to the current drug pricing system and a scientific approachshould be ensured in the process,the scheme introduced in April 2019 relies on a single measure such as the
Incremental Cost Effectiveness Ratio (ICER), but this indicator does notreflect the full value of a medicine and its value varies widely depending on
the choices of data, assumptions and models. Disease severity, unmet need,ethical, and societal considerations should be considered as additional
factors in evaluating the true value of drugs. Significant additional values thatnew medicines bring about need to be assessed comprehensively andtransparently, involving multiple stakeholders including patients. Through thisapproach Japan should establish a more balanced HTA system,
the time frame for company analysis, which is currently predetermined as only
nine months (or three to six months, excluding pre-analysis discussions),
should be flexible, based on the product profile and company’s workload
reflecting the pre-analysis consultation results,
careful use and interpretation of the estimated ICER values is required as
ICERs calculated from models based on various data and assumptions
inevitably contain uncertainties, andall stakeholders, including clinical experts from both public analysis team andindustry, should fully participate in the discussion of refining the newly
introduced system to ensure that the experiences and failures of othercountries are duly evaluated and considered.

HTA for Medical Devices should be introduced with caution
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The BRT calls on the Japanese Authorities to:•be prudent in the introduction of HTA (Health Technology Assessment)
systems for Medical Devices taking into account the following factors:- it is difficult to apply QALY, an indicator often used in HTA evaluation forpharmaceutical products, to the evaluation of medical devices;- users’ skills and techniques of each medical device can affect theevaluation;- medical devices have a shorter improvement cycle than pharmaceuticals.

The BRT believes that:•

it is important that HTA systems do not hinder the creation of innovative
products, delay the listing for medical insurance reimbursement, or impose
an excessive burden on industry (e.g. development of databases or adding
human resources). Such outcomes would delay patient access to cuttingedge medical technologies. To avoid this, there should be a clear distinction
and balance between assessment and appraisal. There should be no
inappropriate use of the ICER measure.

WP-2 / # 08* / EJ to J
A harmonized approach for integration of health-related data andconstruction of data health infrastructures
The BRT calls on the Japanese Authorities to:••foster a harmonized approach for integration of health-related data andstrongly promote construction of data health infrastructures in Japan, andaccelerate the integration according to the grand design under crossministerial guidance.

The BRT believes that:•••

personal health records (PHR) will directly contribute to individual patients’choice of personalised treatments,
the integrated health data will promote evidence-based policy making in
health areas to improve efficiency of healthcare, medical services and nursing
care, andutilization of the big data by academia and industries will lead to new products
and services.

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WP-2 / # 09 / EJ to J
Reinforcement of infectious disease control and vaccine policies
The BRT calls on the Japanese Authorities to:
•
•

•
•

accelerate international harmonization of vaccine regulations and minimize
Japan-specific standards to offer access to vaccines to people in Japan
without delay,
promote regulatory reform to enable flexible regulatory decision-making
depending on the evidence level and urgency, including improvement of theEmergency Use Authorization (EUA) system and expansion of the use of theconditional approval system,
oppose a waiver on intellectual property rights on COVID-19 vaccines andtherapeutics, andreinforce infectious disease control, preventive medicine and vaccine policies,
including the national immunization program, using learnings from the
COVID-19 pandemic.

The BRT believes that:•••the people in Japan suffer disadvantage from delayed access to COVID-19
vaccines, largely resulting from a lack of international regulatory
harmonization and limited agility in regulatory systems to respond to the
public health emergency. The BRT welcomes MHLW’s plan to expedite theregulatory processes for emergency cases. Japan-specific standards should
be minimized and fast access to vaccines and therapeutics should beensured for the people in Japan,
waiving patents on COVID-19 vaccines would not assist capacity expansionof COVID-19 vaccines but only induce risk of counterfeit vaccines and negate
any innovation-based response to future pandemics, andinvesting in preventive medicine and infectious disease control is one of theimportant pillars for our healthcare system to ensure healthy and safe society.
It requires a robust national strategy and upfront investment to promote
vaccine development and infectious disease control.

WP-2 / # 10 / EJ to J
Fostering bio-economy by encouraging small-to-mid-sized enterprises,
such as start-up companies
The BRT calls on the Japanese Authorities to:•enhance support for development of business environment and promote increating innovations driven by small and medium-sized enterprises, such as
start-up companies under the Pharmaceutical Industry Vision 2021 and theaction plans in Bio Strategy 2020, authorized by the GOJ.
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The BRT believes that:••

supporting start-up companies, from every aspect of their business activities,
such as research, development, human resources, funding etc., is importantfor innovation in the Healthcare sector, andplanning and implementation of specific measures for this bio-strategy allows
for an early opportunity to cooperate and collaborate with European
stakeholders engaged in the bio-economy promotion in EU and Japan, to aim
at a sustainable development of the economy in both EU and Japan.

PLANT PROTECTION & BIOTECHNOLOGY
WP-2 / # 11* / EJ to J
The review period for Biotechnology products should be shortened
The BRT calls on the Japanese Authorities to:•••further shorten the review period through harmonization in data requirements
for biotechnology products as well as dossier on human & environment safety,
and through acceptance of summaries in English, as well as
take advantage of the evaluation results from foreign countries in order toreduce the resource burden on the Japanese authorities, andexpand the scope of the biotechnology products for which local confined fieldtesting may be excluded to genetically-modified soybean and other crops
based on accumulated evidence and scientific justification by leveraging datafrom foreign countries.

The BRT believes that:
•

•
•

•

delivering novel and safe seeds is vital for meeting the needs for food of thegrowing world population. While R&D-intensive companies are continuously
and heavily investing in new technologies, the innovation will not contributeto food production without their governmental approval. Hence, early market
access to novel plant protection products is crucially important,a delayed market access of novel products will cause technology gaps,
resulting in unnecessary disadvantages for farmers due to limited access toinnovative products,
further progress in shortening the reviewing period would bring Japan muchcloser to international best practice standards, while the BRT acknowledges
the shortened time to market for new active substance of crop protection
products, andharmonizing international data requirements will enable the industry to avoid
duplicated investment for market access in the respective area. Currently only
China and Japan request local confined field testing for GMO crops for importuse, while other import countries like EU, South Korea and Taiwan leverage
the field data collected in cultivation countries for safety assessment.

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Recommendations from European industries
HEALTHCARE
WP-2 / # 12 / E to J
Requirements for Japanese versions of the clinical trial protocol andinvestigator’s brochure should be relaxed
The BRT calls on the Japanese Authorities to:•accept clinical trial protocols and investigator’s brochures as well as
applications, which are written only in English.

The BRT believes that:••

acceptance of English-only protocols and investigator’s brochures would
reduce costs and make innovative drugs earlier available to patients in Japan,
andthe requirement for translation of the original English version of a clinical trial
notification is delaying the start of patients’ enrolment in Japan.

LIFE SCIENCE & INDUSTRIAL CHEMICALSWP-2 / # 13 / E to J
English translations for issued regulations
The BRT calls on the Japanese Authorities to:•provide English translations of all issued regulations from METI (Ministry of
Economy, Trade, and Industry) and MHLW at the same time as, or shortly
after, the announcement in Japanese.

The BRT believes that:•Japan’s regulating authorities should provide English translations of issued
regulations, adapting to global practice and thereby enhancing Japan’s
presence in the world market.

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WP-2 / # 14 / E to J
Provide a reference to CAS numbers in regulations for Chemical
substances
The BRT calls on the Japanese Authorities to:•indicate CAS (Chemical Abstract Services) numbers in addition to chemicalcompound names in regulations issued by authorities, as has become a
global practice.

The BRT believes that:•

if METI and MHLW regulations would refer to Chemical Abstracts Service(CAS) numbers in addition to chemical compound names, risks of differinginterpretations and varying degrees of regulatory compliance can be avoided.
In addition, swift and accurate internal alignment of concerned companies
could be ensured.

WP-2 / # 15 / E to J
Align naming requirements for product labels of chemicals with the names
used in Japanese law
The BRT calls on the Japanese Authorities to:•revise the labelling requirement of the Poisonous and Deleterious SubstanceControl Law (PDSCL) to indicate chemicals in accordance with the namingused in Japanese law instead of stating the specific names of the included
substance.

The BRT believes that:••a harmonization of the labelling requirement regulations (PDSCL, ISHL andPRTR) to list the contained chemical “as regulated by the Japanese law” on
the label would allow users to quickly assess the toxicity and regulatory
relevance of the materials they handle, andthe discrepancies between naming in Japanese regulations and productlabelling requirements pose a risk that substances are used without a clear
understanding of the regulations they relate to. This should be avoided.

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Recommendations from Japanese industries
ANIMAL HEALTH
WP-2 / # 16 / J to EJ
Ensure mutual recognition of GMP for Animal Health products
The BRT calls on the EU and Japanese Authorities to:••agree on the mutual recognition of European and Japanese marketing
authorizations for veterinary products, starting with mutual recognition of
GMP certification of veterinary medicines, andinclude veterinary products within the scope of the MRA (Mutual Recognition
Agreement).

The BRT believes that:•mutual recognition of GMP certification for veterinary products between the
EU and Japan will provide for faster access to new useful products.

INDUSTRIAL CHEMICALSWP-2 / # 17 / J to E
The draft regulations on microplastics for cosmetics in EU under REACH(regulation for chemicals) should be reconsidered
The BRT calls on the EU Authorities to:•derogate all wiped-off cosmetic products (make-up, lip and nail products) fromthe restriction of microplastics.

The BRT believes that:•microplastic emission from make-up, lip and nail cosmetic products to theaquatic environment is insignificant, because they are wiped-off after theiruse and, in addition, they are trapped at sewage treatment systems.
Restriction of make-up, lip and nail cosmetic products does not contribute to
reducing the environmental impact.

(Document ends)

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