To those responsible for exporting machines equipped with PLCs, touch panels, and network connections to the EU, which may also include CE-marked products: "We are already compliant with CE marking and are progressing towards compliance with the Machinery Directive." — However, after December 2027, there may be another regulatory compliance requirement. The EU Cyber Resilience Act (CRA: Regulation (EU) 2024/2847) is the EU's first horizontal cybersecurity regulation that applies to all products capable of processing and exchanging digital data. The CRA is a regulation that applies separately from the Machinery Directive and Machinery Regulations. In this issue, we will organize the requirements for documentation that the CRA mandates, based on the text of the regulation, and inform you of the differences from existing documentation and the preparations that should be undertaken now.

When companies start considering overseas expansion, many feel, "I don't know where to begin." Not only do they need to develop sales channels and conduct market research, but they also have to obtain certifications and comply with regulations, which can be a significant burden if they try to proceed on their own. However, by utilizing the programs offered by public institutions and local governments that support overseas expansion, they may be able to reduce the burden of information gathering and costs.

On August 12, 2026, the full application of the EU's new packaging regulation, the PPWR (Packaging and Packaging Waste Regulation), began. As a result, inquiries regarding PPWR and EPR have increased at overseas certification PROs. "Are our products subject to this?" "Is EPR registration necessary?" "What should we confirm with our packaging material suppliers?" "We are CE compliant, but are there additional requirements?" Many companies seeking advice on these matters are unsure about the extent of the impact on their business and the necessary actions, causing them to hesitate in the information-gathering stage. The PPWR is not just an environmental regulation; it is a system that also relates to the packaging design and document management of companies supplying products to the EU market. This article will outline the overview of the system and the points that companies should verify.

In the previous issue (Vol. 3), we organized the impact of the transition to machine regulations on the practical aspects of instruction manual creation. This time, we will take a further step and focus on the practical aspects of the design process regarding "when, who, and how should instruction manuals be created." In response to the question of "when should we start writing the instruction manual," the standard provides a clear answer. ISO 12100 requires that the results of risk assessment be reflected in three stages: design, protective measures, and information provision, positioning the instruction manual as the final output of the design process under "information provision." Practically speaking, it is ideal to start creating the instruction manual simultaneously from the stage of defining requirements and initiating the initial risk assessment. In this issue, we will clarify the relationship between the ISO 12100 three-step method and instruction manuals, outline specific instruction manual tasks and internal role distribution for each design phase, and present four checkpoints that should be incorporated into the design review.

In the previous issue (Vol. 2), we organized the common deficiencies pointed out in the instruction manuals. In this article, as a continuation, we will specifically explain the changes in the instruction manuals resulting from the transition from the Machinery Directive to the Machinery Regulation. As of January 20, 2027, the regulations applicable to machinery exports to the EU market will switch from "Machinery Directive 2006/42/EC" to "Machinery Regulation EU 2023/1230." The change from "Directive" to "Regulation" is not just a matter of terminology. There are several changes that require direct attention from those responsible for technical documentation and instruction manuals. In this issue, we will outline the impact of the transition to the Machinery Regulation on practical instruction manual work and highlight the points that should be addressed starting now.

CRA: The reporting obligations under the European Cyber Resilience Act will begin in September 2026. In preparation for Article 14, which mandates the reporting of vulnerabilities and significant incidents, companies such as industrial machinery manufacturers and electronics manufacturers are working to establish internal systems. Did you know that "Our products do not connect to the internet" and "We have previously declared CE marking for products, but we are not currently selling them" could also fall under the scope of the CRA? In this "free assessment," you can clarify what you should do first under the CRA by simply answering five questions.

Tender Loving Care Service Co., Ltd. will hold a free online seminar titled "What You Should Know by Your Fifth Year of Employment! Understanding Overseas Export and CE Marking" To launch industrial machinery in Europe, it is essential to understand CE marking, machine safety, and EMC. The basics of overseas export, including CE marking, that you should know by your fifth year of employment. This seminar will help you understand the overall picture of CE marking and assist you in smoothly progressing with CE marking at your company.

We will hold a free WEB seminar titled "Key Points Explanation for Compliance with the EU Cyber Resilience Act (CRA) | Overseas Certification PRO × BVJ." This seminar will clearly explain the new regulations directly related to CE marking. The newly established "Cyber Resilience Act (CRA)" is an essential regulation that companies wishing to market products in Europe cannot afford to overlook. In this seminar, we will invite engineers from BVJ (Bureau Veritas Japan) to explain the basics of the CRA and practical response points, including its relationship with CE marking, in an easy-to-understand manner. We hope this will be useful for understanding the initial steps towards CRA compliance and for internal discussions.

In the previous issue (Vol. 1), we organized the reasons why the instruction manual is pointed out during the review process. In this article, as a continuation, we will specifically explain the common "deficiency patterns." To those in charge of companies aiming for CE certification or who have just completed it: "We have arranged the design and safety measures. Yet, we were pointed out for deficiencies in the instruction manual during the review." Such voices are repeatedly heard in the field of CE compliance. Annex I §1.7.4 of the Machinery Directive/Machinery Regulations establishes the content requirements for the instruction manual as an independent chapter, and the certification body clearly checks that section. Deficiencies in the instruction manual are returned not as design issues but as "document issues." This time, we will organize five recurring deficiency patterns that arise in the review process, along with the relevant standard clauses. Please check this to prevent rework in CE compliance.

Tender Loving Care Service Co., Ltd. will hold a free WEB seminar titled "What You Should Know by Your 5th Year of Employment! Understanding Overseas Exports and CE Marking for the First Time." To launch industrial machinery in Europe, it is essential to understand CE marking, machine safety, and EMC. This seminar covers the basics of overseas exports, including the CE mark, that employees should know in their first to fifth years. In this seminar, you will gain a comprehensive understanding of CE marking, which will help you smoothly advance CE marking within your company.

We will hold a free WEB seminar titled "Practical Response to the EU Machinery Regulation." Starting January 2027, the legal regulations for machinery aimed at the EU will completely transition from the "Machinery Directive (2006/42/EC)" to the "Machinery Regulation (EU 2023/1230)." In this seminar, we will invite an external lecturer with extensive practical experience regarding the EU Machinery Regulation to clearly explain the new trends and practical considerations that Japanese companies should be aware of. This content is recommended not only for companies that will be designing, manufacturing, and exporting machinery and equipment for the EU, but also for those considering a review of existing products.

This column is a special series consisting of 12 installments themed around user manuals. In the first installment, we will focus on the often-overlooked "risks of postponing the user manual" in relation to CE marking compliance. In the process of obtaining CE marking, attention is often concentrated on design and safety measures, leading to cases where the preparation of the user manual is delayed. However, in practice, deficiencies in the user manual can lead to the following issues: - Rejection just before the review - Increased costs due to design revisions - Schedule delays - Product liability (PL liability) risks after shipment Even if CE marking is obtained, it is important to be aware that insufficient information provision can leave risks associated with the product.

We will be holding a free webinar titled "Essential Before Entering the European Business: Understanding and Addressing EU Regulations Related to Products, Packaging, and Labels." For companies exporting and selling products to Europe, compliance with EU regulations is unavoidable. However, the regulations concerning products, packaging, and labels are diverse, and many companies feel uncertain, wondering, "Where should we start checking?" and "Are we really compliant?" In this seminar, we will clearly explain the overall picture of the key EU regulations that should be organized before starting European business, as well as introduce practical points for regulatory checks that companies should implement first. This content is recommended not only for companies considering expansion into Europe but also for those already exporting to Europe who feel anxious or face challenges regarding regulatory compliance. We sincerely look forward to your participation.

We plan to hold various free seminars from April to September 2026. Focusing on themes directly related to practical work, we will clearly explain advanced trends and specific response points. We encourage all stakeholders to utilize this opportunity as a valuable source of information. Details of each seminar (dates, methods, participation requirements, application procedures, etc.) will be announced on our company website as soon as they are finalized.

We are pleased to announce that Overseas Certification PRO will be exhibiting at the "Overseas Business EXPO 2025 Osaka," one of the largest exhibitions in Japan focused on overseas business information. Our company will be at Booth 038. This will be a casual opportunity to consult about CE marking, testing, certification, and other export-related regulations. We hope you will take advantage of this opportunity to gather information and build your network. We provide one-stop support for certifications and conformity declarations from various countries around the world, including not only the European CE mark but also the United States (NRTL, UL), China (CCC), and South Korea (KC, KCs). This year, with the Osaka-Kansai Expo, we anticipate a rapid increase in inbound demand in Japan. The synergy between "inbound" and "overseas expansion" is expected to be the key to unlocking new growth in the global market. We encourage you to visit us! *Entry is free for those who register in advance on our website or bring an invitation ticket. ▶For more details, click here https://tenderlove-pcb.biz/expo2025oosaka/

To launch industrial machinery in Europe, understanding CE marking, machine safety, and EMC is essential. The basics of overseas exports, including the CE mark, that you should know within your first 1 to 5 years of employment. By taking this course, you will gain a comprehensive understanding of CE marking and be able to smoothly advance CE marking within your company. 【Recommended for】 - Individuals in their first 1 to 5 years of employment (those with more experience are also welcome) - Employees of companies dealing with industrial machinery or industrial electronic devices - Quality assurance practitioners - Overseas sales and promotion personnel - Beginners to intermediate learners of CE marking 【Agenda】45 minutes - CE marking (Europe) and other overseas certifications - Why CE marking? - Key directives and regulations to be aware of - What happens if you violate them? What penalties are there? - Practical implementation starting today 【Regarding Q&A】 - Since the characteristics vary by product and there may be confidential information involved, we will provide separate time for individual consultations this time. Individual consultations* are also "free," so please feel assured to participate. *If you wish to have a consultation, please indicate this in the comments section from "Details & Application."

To launch industrial machinery in Europe, understanding CE marking, machine safety, and EMC is essential. The basics of overseas exports, including the CE mark, that you should know within your first 1 to 5 years of employment. By taking this course, you will gain a comprehensive understanding of CE marking, which will help you smoothly advance CE marking within your company. [Recommended for] - Individuals in their first 1 to 5 years of employment (those with more experience are also welcome to participate) - Employees of companies dealing with industrial machinery or industrial electronic devices - Quality assurance practitioners - Overseas sales and promotion personnel - Beginners to intermediate learners of CE marking [Agenda] 45 minutes - CE marking (Europe) and other overseas certifications - Why CE marking? - Key directives and regulations to understand - What happens if you violate them? What penalties are there? - Practical implementation starting today [Regarding Q&A] - Since the characteristics of products vary and there may be confidential information involved, we will provide separate time for individual consultations this time. Individual consultations* are also "free," so please feel assured in attending. *If you wish to have a consultation, please indicate this in the comments section under "Details & Application."

We, Overseas Certification PRO (Tender Loving Care Service Co., Ltd.), have created a technical document summarizing the basic knowledge necessary for exporting to the EU and CE marking. It is available for anyone to download, so please take this opportunity to check it out. We are also currently holding a limited-time free WEB seminar. What you need to know by your fifth year of employment! The basics of overseas export and CE marking for beginners. Event Dates: April 14 (Monday) 11:00-11:45 (Registration closed) April 23 (Wednesday) 15:00-15:45 (Registration closed) May 12 (Monday) 11:00-11:45 May 21 (Wednesday) 15:00-15:45 Fundamentals of overseas export, including CE marking, that you should know by your first to fifth year of employment. By attending this course, you will gain a comprehensive understanding of CE marking, which will help you smoothly proceed with CE marking in your company. If you have specific inquiries, we will respond promptly. Please feel free to contact us. Contact: Kobayashi Email: global@tenderlove.co.jp TEL: 03-6267-7032 (Business hours: Weekdays 9:00-18:00)

This seminar is aimed at companies that have previously made self-declarations (CE marking, UKCA) and manufacturers considering expanding into overseas markets such as Europe and the UK. We will provide an overview of the Machinery Regulation and explain specifically how it will change, using case studies for illustration. For those who feel, "It seems difficult..." or "I might not be able to handle it," we will break it down to make CE marking feel more accessible. 【What you will learn in this seminar】 - A review of the basic knowledge and latest information on CE marking - Transitioning from the Machinery Directive to the "Machinery Regulation." We will clarify the differences between directives and regulations. - An overview of the Machinery Regulation (2023/1230/EU) and a detailed explanation of the necessary points. 【Recommended for the following individuals】 - Companies that have previously declared CE marking or UKCA - Manufacturers of industrial machinery considering exports to Europe and the UK - Individuals responsible for overseas certifications such as CE marking and UKCA - Companies in industrial machinery or industrial electronic devices - Quality assurance practitioners - Overseas sales and promotion personnel - Beginners to intermediate learners of CE marking We hope you will take this opportunity to listen.

This seminar is aimed at companies that have previously made self-declarations (CE marking, UKCA) and manufacturers considering expanding into overseas markets such as Europe and the UK. We will provide an overview of the Machinery Regulation and explain how it will specifically change, using case studies for clarity. For those who may feel, "This seems difficult..." or "I might not be able to handle it," we will break it down to make CE marking feel more accessible. 【What you will learn in this seminar】 - A review of the basic knowledge and latest information on CE marking - Transitioning from the Machinery Directive to the "Machinery Regulation." We will clarify the differences between directives and regulations. - An overview of the Machinery Regulation (2023/1230/EU) and a detailed explanation of the necessary points. 【Recommended for the following individuals】 - Companies that have previously declared CE marking or UKCA - Manufacturers of industrial machinery considering exports to Europe and the UK - Individuals responsible for overseas certifications such as CE marking and UKCA - Companies in industrial machinery or industrial electronic devices - Quality assurance practitioners - Overseas sales and promotional staff - Beginners to intermediate learners of CE marking We hope you will take this opportunity to listen.

This seminar is aimed at companies that have previously declared CE marking and UKCA, as well as manufacturers considering expansion into overseas markets such as Europe and the UK. We will provide an overview of the Machinery Regulation and explain specifically how it will change, using case studies for illustration. For those who feel that it seems complicated or that they might not be able to cope, we will break it down to make CE marking feel more accessible. 【What you will learn in this seminar】 - A review of the basic knowledge and latest information on CE marking - Transitioning from the Machinery Directive to the Machinery Regulation: an explanation of the differences between directives and regulations - An overview of the Machinery Regulation (2023/1230/EU) and a detailed explanation of the necessary points 【Recommended for】 - Companies that have previously declared CE marking and UKCA - Manufacturers of industrial machinery considering exports to Europe and the UK - Individuals responsible for overseas certifications such as CE marking and UKCA - Companies in the industrial machinery/electronic equipment sector - Quality assurance practitioners - Overseas sales and promotion personnel - Beginners to intermediate learners of CE marking We hope you will take this opportunity to attend.

We will hold a free seminar on EMC testing strategies and fundamentals for industrial machinery and industrial electronic devices. This seminar will feature a special guest speaker, so we encourage you to participate actively. Speaker: Mr. Shibuya / Manager of EMC Testing at Certification Agency He primarily handles EMC testing, evaluation, and strategies for wireless devices and automotive electrical and electronic equipment in the Connectivity EMC department (Connectivity Wireless/Auto) at SGS Japan. From 1980 to 2020, he was engaged in work related to EMC design, strategies, and evaluation of electrical products that are highly compatible with his current role. After retiring, he utilized his knowledge and experience in EMC at one of the world's leading electronic component manufacturers, where he was involved in the development of EMC countermeasure components, EMC business in China, and EMC strategies. Since 2022, he has been involved in the establishment of the automotive EMC business at SGS Japan and is currently engaged in supporting EMC strategies across a wide range of industries, from aircraft to industrial machinery, both domestically and internationally. ■ Recommended for: - Manufacturers of industrial equipment and industrial electronic devices - Designers - Personnel responsible for overseas certification - Those considering CE marking in the future - Those who have previously declared CE marking but wish to update their information

- This seminar has reached full capacity due to its popularity. - We will provide an overview of the Machinery Regulation and explain how it will change, with examples, for companies that have previously declared compliance (CE marking, UKCA) and for manufacturers considering entering overseas markets such as Europe and the UK. For those who feel, "It seems difficult..." or "I might not be able to handle it," we will break it down to make CE marking feel more accessible. [What you can learn in this seminar] - A review of the basic knowledge and latest information on CE marking - An explanation of the transition from the Machinery Directive to the "Machinery Regulation," clarifying the differences between directives and regulations - An overview of the Machinery Regulation (2023/1230/EU) and a detailed explanation of the necessary points We hope you will take this opportunity to attend.

ISO13849-1:2023 "Safety-related parts of control systems: General principles for design" has been completely revised and issued for the first time in eight years since the previous edition in 2015. Furthermore, it will be published in the Official Journal of the European Union as EN ISO 13849-1:2023 on May 16, 2024, and the previous edition from 2015 will expire on May 15, 2027. This seminar will provide an overview of the significant revisions regarding the creation of the Safety Requirements Specification (SRS) and its validation, focusing on what machine manufacturers should consider before the design phase of safety-related parts of control systems. Recommended for: Design/development personnel of industrial machinery/equipment (such as machine tools, industrial robots, assembly equipment, semiconductor manufacturing equipment, industrial printing machines, etc.) This standard is a harmonized standard for the Machinery Directive and Machinery Regulations. As it is a very important group safety standard, we believe it is a necessary issue for each manufacturer and company to address. We hope you will take this opportunity to attend.

In Europe, when CE marking electrical and electronic equipment, compliance with multiple regulations and directives is required even for a single product. This webinar aims to provide an efficient structure to learn about these matters in one session. It is recommended for those who want to understand what specific actions are necessary for CE marking their own products (electrical and electronic equipment). <Goal> To understand the legal requirements when selling electrical and electronic equipment in Europe. <Target Audience> Those who want to know what actions are necessary for CE marking their own products. Those who want to learn an overview of CE marking all at once. Those considering expanding into the European market, etc. Theme: Basics of CE Marking for Electrical and Electronic Equipment Manufacturers Agenda ◆ Overview of CE marking ◆ Overview of main directives applicable to electrical and electronic equipment (Low Voltage, EMC, Machinery, Radio Equipment, RoHS, Eco-design) ◆ Selection of harmonized standards ◆ Implementation of conformity assessment ◆ Preparation of technical documentation and EU declaration of conformity ◆ Maintenance and management after CE marking compliance

Tender Loving regularly holds CE marking seminars. The upcoming CE marking seminar will focus on the Machinery Directive. We will welcome an expert in machinery safety as a lecturer, aiming to efficiently master the extensive CE requirements through two weeks of lectures. Theme: Two-week event - Let's deepen our understanding! CE marking for machinery, Part 1 & Part 2 Date and Time: "Part 1" June 23 (Thursday) 13:00 - 15:00 (2 hours) "Part 2" June 28 (Tuesday) 13:00 - 16:00 (3 hours) Venue: Online via ZOOM meeting Participation Fee: Free (You can attend both parts or just one of them) - Agenda "Part 1" June 23 (Thursday) 13:00 - 15:00 (Total 2 hours) 1. CE marking system (1 hour) 2. Implementation guidelines for risk assessment (1 hour) "Part 2" June 28 (Tuesday) 13:00 - 16:00 (Total 3 hours) 1. Overview of safety and health requirements of the Machinery Directive (1 hour) 2. Overview of IEC 60204-1 electrical requirements for machinery (1 hour) 3. Overview of the EMC Directive (1 hour)

Date and Time: December 16, 2022 (Friday) 13:00 – 16:10 (Lecture 60 minutes x 3 sessions, Networking event after the lecture until 17:00) Venue: Dojima Building 1st Floor, Rental Conference Room B Address: 2-6-8 Nishitenma, Kita-ku, Osaka City, Osaka Prefecture Participation Fee: Free Capacity: 20 people Instructor: Mr. Yasushi Yoshikawa (Representative Director of Face Co., Ltd., Specialist Consultant at MTEP City Technology Research Institute) 【Agenda】 1. CE Marking System (13:10 – 14:00 / 50 minutes) - Features of CE marking - Disclosure of illegal activities and violation cases - Framework of directives and regulations - Conformity assessment procedures - Technical files, labeling, declaration of conformity - Overview of UKCA marking - Overview of Machinery Directive, EMC Directive, Low Voltage Directive, RoHS Directive 2. Electrical Requirements in Machine Design (14:00 – 15:00 / 60 minutes) - Overview of IEC 60204-1 General Electrical Requirements 3. Mechanical Requirements in Machine Design (15:10 – 16:10 / 60 minutes) - Overview of safety and health requirements of the Machinery Directive - Practical methods for risk assessment Networking Event (16:10 – 17:00 / 50 minutes, free to leave)

As you all know, there has been an increase in companies trying to expand their markets overseas due to the recent depreciation of the yen. (Especially in industrial machinery, electrical products, components, semiconductor manufacturing equipment, EV-related equipment, toys, and protective gear.) Global product safety is defined by countries such as Japan (JIS), Europe (CE), the UK (UKCA), Canada (CSA), North America (NRTL, FieldLabel), China (CCC), and South Korea (KC, KCs), in compliance with ISO and IEC standards set by the WTO. Not understanding these regulations can lead to various problems. "Overseas Certification PRO" assists with the declaration and acquisition of safety certifications for products aimed at Europe and North America. We have received many inquiries from domestic and overseas (Japanese companies) and have discussed and resolved issues such as the following examples: 1. Stopped at customs 2. Requested by end-users during business negotiations 3. Wanting to reduce costs for declarations and certifications 4. Seeking information about the regulations, etc. I will discuss what the first step is towards the declarations and certifications required by various countries when expanding overseas, as well as the key points of the regulations.

We will be exhibiting at the Overseas Business EXPO Tokyo, one of the largest exhibitions in Japan focused on overseas business. This event will provide a casual setting to discuss topics such as CE marking, testing, certification, and other export-related regulations. We look forward to meeting everyone and hope you will join us. Event Overview Overseas Business EXPO 2023 Tokyo Date: November 28 (Tuesday) - 29 (Wednesday), 2023, 10:00 AM - 5:00 PM Venue: Hamamatsucho Hall, 4th Floor 1-7-1 Kaigan, Minato-ku, Tokyo Our Booth Name: Overseas Certification PRO by Tender Loving Care Service Booth Number: 050 Outbound Admission Fee: Free We welcome appointment requests for meetings. Please feel free to contact us. Tender Loving Care Service Co., Ltd. Global Access Division "Overseas Certification PRO" Contact: Yamazaki, Yamaguchi, Kobayashi

Seminar on the Concept of CE Marking for Industrial Machinery and Electronic Equipment for Industry Date: February 20 (Tuesday) 13:00 - 15:00 Venue: Shin-Marunouchi Center Building, 21st Floor (Location has changed) Participation Fee: Free Capacity: 6 companies *Additional seats added → Fully booked Instructor: Manabu Yamazaki / Overseas Certification PRO Manager 【Recommended for】 - Companies in industrial machinery / electronic equipment for industry - Quality assurance practitioners - Overseas sales / promotion personnel - Beginners to intermediate learners of CE marking 【Course Highlights】 To launch industrial machinery in Europe, understanding CE marking, machine safety, and EMC is essential. By attending this course, you will gain a comprehensive understanding of CE marking and be better equipped to smoothly advance CE marking in your company. 【Agenda】 - Basic knowledge of CE marking - From Machinery Directive to Machinery Regulation - Break time - Overview of Cyber Resilience