2024全球市場准入法規更新訊息
2024全球市場准入法規更新訊息
歐洲議會和理事會已於2023年5月10日採納了新的通用產品安全法規EU 2023/988，此法規對法規(EU) No 1025/2012和指令(EU) 2020/1828進行了補充，並替代指令2001/95/EC和87/357/EEC 。
本法規整體具有法律約束力，可直接適用於所有歐盟成員國。它於2023年6月12日生效，並將於2024年12月13日開始實施。目前的通用產品安全指令2001/95/EC，將於2024年12月13日廢除。
歷經20多年的發展與變化，消費產品的安全依然是歐盟深度關切的主題。與通用產品安全指令2001/95/EC相比，新的通用產品安全法規 (EU) 2023/988的要求發生了一系列重大調整，包括：
a. 將未被歐盟協調立法覆蓋的產品的要求與支撐歐盟協調立法的新法律框架內容進一步相協調，例如通用定義（經濟營運商和投放市場等），經濟營運商的通用義務（技術文件和通報危險產品等），歐盟責任人，以及歐盟市場監管活動等。
b. 對歐盟所有消費產品的通用措施進行統一，包括遠端銷售，事故處理，安全門，召回通知和補救措施等。
c. 伴隨新技術的不斷發展，例如網路安全和人工智慧，進一步完善產品的安全要求。
d. 鑒於線上銷售的廣泛使用，規範線上市場提供商的責任和義務。
e. 強化“安全門”的產品安全線上預警和通報機制，以取代原有的RAPEX系統。
新法規的市場監管活動將與2024年12月13日展開。成員國應在2024年12月13日前制定適用於違反新法規的處罰細則。
以下是新“通用產品安全法規”的重要措施節選。
The European Parliament and the Council adopted on May 10th, 2023 the new Regulation (EU) 2023/988 concerning general product safety, amending Regulation (EU) No 1025/2012 and Directive (EU) 2020/1828 and repealing Directive 2001/95/EC and 87/357/EEC.
This Regulation is binding in its entirety and directly applicable in all EU Member States. It entered into force on June 12th, 2023 and applies from December 13th, 2024. The present General Product Safety Directive 2001/95/EC will be repealed from December 13th, 2024.
After more than 20 years of development and change, the safety of consumer goods still remains a subject of deep concern for the EU. The requirements of new General Product Safety Regulation (EU) 2023/988 has series of significant adjustments comparing with General Product Safety Directive 2001/95/EC, including:
a. Further harmonization with the elements of the New Legislative Framework which is supporting Union Harmonisation Legislations on the products not covered by Union harmonization Legislation, such as common definitions (economic operators and placing on the market etc.), common obligations for economic operators (technical documentation and notification of dangerous product etc.), EU responsible persons, and EU market surveillance activities and so on.
b. Unification of general measures to all EU consumer products including distance sales, incident management, Safety Gate, recall notice and remedies etc.
c. Along with the continuous development of new technologies, such as cybersecurity and artificial intelligence, further improvement of the safety requirements of products.
d. Regulate the responsibilities and obligations of providers of online marketplaces in view of the widespread use of online sales.
e. Strengthen the product safety online alert and notification mechanism of Safety Gate to replace the original RAPEX system.
Market surveillance activities of new Regulation will be started from December 13th of 2024. Member States shall lay down the rules on penalties applicable to infringements of this Regulation by December 13th 2024.
The excerpt of new General Product Safety Regulation is as follows.
本法規制定了投放市場或在市場上流通的消費產品的安全的基本要求。
The Regulation lays down essential rules on the safety of consumer products placed or made available on the market.
本法規適用於投放市場或在市場上流通的產品，這些產品在歐盟法律中沒有具有相同目標的特定條款來規範相關產品的安全*。
This Regulation applies to products that are placed or made available on the market as there are no specific provisions with the same objective under Union law which regulate the safety of the products concerned*.
對於受歐盟協調立法具體要求約束的產品：
a. 第二章安全要求不適用於歐盟協調立法已涵蓋的風險或風險類別*。
b. 第三章第二節（經濟運營商的義務 — 遠端銷售、事故通報、電子格式資訊）、第四章（線上市場提供商）、第六章（安全門快速報警系統和安全業務閘道）以及第八章（知情權和補救權）適用。
With regard to products subject to specific requirements imposed by Union harmonisation legislation：
a. Chapter II (Safety requirements) does not apply insofar as the risks or categories of risks covered by Union harmonisation legislation are concerned*;
b. Chapter III Section II (Obligations of economic operators – Distance sales, accident notification, information in electronic format), Chapters IV (Providers of online marketplaces), VI (Safety gate rapid alert system and safety business gateway), VIII (Right to information and to a remedy) applies.
本法規不適用於：
a. 人用或獸用藥品；
b. 食品；
c. 飼料；
d. 活的植物和動物、封閉使用的轉基因生物和轉基因微生物，以及與其未來繁殖直接相關的植物和動物產品；
e. 動物副產品及衍生產品；
f. 植物保護產品；
g. 消費者乘坐或旅行的設備，該設備由服務提供者在向消費者提供的運輸服務範圍內直接操作，而不是由消費者自己操作；
h. 法規 (EU) 2018/1139 第 2 (3)條 (d) 點提及的航空器；
i. 古董。
This Regulation does not apply to:
a. Medicinal products for human or veterinary use;
b. Food;
c. Feed;
d. Living plants and animals, genetically modified organisms and genetically modified microorganisms in contained use, as well as products of plants and animals relating directly to their future reproduction;
e. Animal by-products and derived products;
f. Plant protection products;
g. Equipment on which consumers ride or travel where that equipment is directly operated by a service provider within the context of a transport service provided to consumers and is not operated by the consumers themselves;
h. Aircraft referred to in Article 2(3), point (d) of Regulation (EU) 2018/1139;
i. Antiques.
產品是指任何物品
Product
any item,
歐盟協調立法：
Union harmonisation legislation
*風險未被其他歐盟法律覆蓋的情形包括：
a. 某些產品，產品安全未被任何歐盟協調立法覆蓋，例如傢俱，運動器材等，或未來的新產品；
b. 某些產品特性，產品安全未被相關歐盟協調立法覆蓋，例如帶有軟體更新的自進化功能。
*Risk not covered by other Union law could be:
a. Certain products, safety is not covered by any Union harmonization legislation, such as, furniture, sport equipment etc., or new product in the future etc.
b. Certain characters of product, safety may not be covered by the Union harmonization legislation, such as evolving functionalities with software update.
[風險未被其他歐盟法律覆蓋* risk not covered by other Union law*]
需要評估的安全方面：
a. 產品的特性，包括其設計、技術特點、成分、包裝、組裝說明以及適用的安裝、使用和維護說明；
b. 對其他產品的影響，如果可以合理預見該產品將與其他產品一起使用，包括這些產品的互連；
c. 當合理預見到其他產品將與該產品一起使用時，其他產品可能對該產品產生的影響，包括旨在確定、改變或完成待評估產品的工作方式的非嵌入式產品的作用，在評估待評估產品的安全性時必須予以考慮；
d. 產品的展現、標籤，包括有關兒童年齡適宜性的標籤、安全使用和處置的任何警告和說明，以及有關產品的任何其他指示或資訊；
e. 使用產品的消費者類別，特別是評估兒童、老年人和殘疾人等弱勢消費者的風險，以及性別差異對健康和安全的影響；
f. 產品的外觀可能導致消費者以與其設計目的不同的方式使用該產品，特別是：
(i) 產品雖然不是食品，但與食品類似，並且由於其形狀、氣味、顏色、外觀、包裝、標籤、體積、尺寸或其他特徵而可能與食品混淆，因此可能被放入口中 ，被消費者，尤其是兒童吮吸或攝入；
(ii) 產品雖然不是為兒童設計或旨在供兒童使用，但很可能會被兒童使用，或由於其設計、包裝或特性而與普遍認為吸引兒童或旨在供兒童使用的物體相似。
g. 當產品性質需要時，保護產品免受外部影響（包括惡意第三方）所需的適當網路安全功能，這種影響可能對產品的安全產生影響， 包括可能失去互連；
h. 當產品性質需要時，產品的不斷進化、學習和預測功能。
Safety aspects to be assessed
a. The characteristics of the product, including its design, technical features, composition, packaging, instructions for assembly and, where applicable, for installation, use and maintenance;
b. The effect on other products, where it is reasonably foreseeable that the product will be used with other products, including the interconnection of those products;
c. The effect that other products might have on the product to be assessed, where it is reasonably foreseeable that other products will be used with that product, including the effect of non-embedded items that are meant to determine, change or complete the way the product to be assessed works, which has to be taken into consideration when assessing the safety of the product to be assessed;
d. The presentation of the product, the labelling, including the labelling regarding age suitability for children, any warnings and instructions for its safe use and disposal, and any other indication or information regarding the product;
e. The categories of consumers using the product, in particular by assessing the risk for vulnerable consumers such as children, older people and persons with disabilities, as well as the impact of gender differences on health and safety;
f. The appearance of the product where it is likely to lead consumers to use the product in a way different to what it was designed for, and in particular:
(i) Where a product, although not foodstuff, resembles foodstuff and is likely to be confused with foodstuff due to its form, odour, colour, appearance, packaging, labelling, volume, size or other characteristics and might therefore be placed in the mouth, sucked or ingested by consumers, especially by children;
(ii) Where a product, although neither designed nor intended for use by children, is likely to be used by children or resembles an object commonly recognised as appealing to or intended for use by children because of its design, packaging or characteristics;
g. When required by the nature of the product, the appropriate cybersecurity features necessary to protect the product against external influences, including malicious third parties, where such an influence might have an impact on the safety of the product, including the possible loss of interconnection;
h. When required by the nature of the product, the evolving, learning and predictive functionalities of the product.
符合通用安全要求的推定：
a. 符合歐盟官方公報上發佈的歐洲標準。
b. 符合成員國國家法律規定的國家要求。
Presumption of conformity with the general safety requirement
a. Conforms to European standards published in the Official Journal of the European Union.
b. Conforms to national requirements laid down in the national law of the Member State.
附加要素，如安全推定不適用
Additional elements where the presumption of safety does not apply
*風險未被其他歐盟法律覆蓋的情形包括：
a. 某些產品，產品安全未被任何歐盟協調立法覆蓋，例如傢俱，運動器材等，或未來的新產品；
b. 某些產品特性，產品安全未被相關歐盟協調立法覆蓋，例如帶有軟體更新的自進化功能。
*Risk not covered by other Union law could be:
a. Certain products, safety is not covered by any Union harmonization legislation, such as, furniture, sport equipment etc., or new product in the future etc.
b. Certain characters of product, safety may not be covered by the Union harmonization legislation, such as evolving functionalities with software update.
[風險未被其他歐盟法律覆蓋* risk not covered by other Union law*]
經濟營運商：
a. 製造商；
b. 進口商；
c. 歐盟授權代表；
d. 經銷商；
e. 履行服務提供者。
Economic operator:
a. Manufacturer
b. Importer
c. Authorised representative
d. Distributor
e. Fulfilment service provider
歐盟責任人：
a. 建立在歐盟境內的製造商；
b. 進口商，如製造商不在歐盟境內；
c. 歐盟授權代表；
d. 履行服務提供者。
EU responsible person:
a. Manufacturer established in the Union
b. Importer where the manufacturer is not established in the Union
c. Authorized representative
d. Fulfilment service provider
技術文件：
a. 產品的總體描述；
b. 風險分析和解決方案；
c. 檢測報告；
d. 歐洲標準、國家要求、或附加要素的清單。
Technical documentation:
a. General description of product
b. Risk analysis and solutions
c. Test reports
d. List of European standards, national requirements, or additional elements
經濟營運商和歐盟責任人的通用義務（節選）
a. 技術文件，產品投放市場後保存10年；
b. 產品識別資訊：型號名、批次或序號碼，或其他識別要素；
c. 製造商，進口商和歐盟責任人的聯繫地址：名稱、注冊商標名稱或注冊商標圖案、郵政和電子位址；
d. 說明和安全資訊;
e. 調查投訴、事故和登記投訴、召回、糾正措施等；
f. 對危險產品採取糾正措施，包括撤銷和召回；
g. 通知消費者、製造商或進口商，市場監管機構危險產品的風險以及採取的糾正措施；
h. 回應市場監管機構的要求，提供資訊和文件，和市場監管機構合作。
General obligation of economic operators and EU responsible persons (Excerpt)
a. Technical documentation, kept for 10 years after product placed on the market;
b. Product identification information: type, batch or serial number, or elements enabling the identification;
c. Contact address of manufacturer, importer and EU responsible person: name, registered trade name or registered trade mark, postal and electronic address;
d. Instruction and safety information;
e. Investigate complaints, accidents, and register of complaints, recalls, corrective actions etc.
f. Take corrective actions for dangerous product, including withdraw or recall;
g. Inform customers, manufacturer or importer, market surveillance authority of risk of dangerous product and corrective actions；
h. Respond request, provide info. and document to market surveillance authority, and cooperate with market surveillance authority.
遠端銷售的基本資訊
Basic information of Distance sales
透過線上或其他遠端銷售方式提供的產品應至少顯示：
a. 在歐盟境內建立的製造商的聯繫地址；
b. 歐盟責任人的聯繫地址，如製造商不在歐盟境內建立；
c. 產品識別資訊；
d. 警告或安全資訊。
The offer of products through online or other means of distance sales shall indicate at least:
a. Contact address of manufacturer established in the Union
b. EU responsible person where manufacturer is not established in the Union
c. Product identification information
d. Warning or safety information
事故通報
Notification of Accident
a. 製造商或歐盟責任人應確保通過“安全業務閘道”通報在市場上投放或提供的產品引起的事故，不得無故拖延；
b. 製造商或歐盟責任人應通知主管當局，其產品的使用導致個人死亡或對該個人的健康和安全造成永久性或暫時性的嚴重不利影響，包括受傷、其他身體損害、疾病 和慢性健康影響；
c. 進口商和經銷商獲知其投放或在市場上提供的產品引起事故後，應立即通知製造商或歐盟責任人。
a. Manufacturer or EU responsible person shall ensure the notification of accident caused by a product placed or made available on the market through Safety Business Gateway without undue delay.
b. Manufacturer or EU responsible person shall notify the competent authorities with the use of a product that resulted in an individual’s death or serious adverse effect on that individual’s health and safety, permanent or temporary, including injuries, other damage to the body, illnesses and chronic health effects.
c. The importers and the distributors which have knowledge of an accident caused by a product that they placed or made available on the market shall inform the manufacturer or EU responsible person without undue delay.
電子格式資訊
Information in electronic format
經濟營運商還可以額外透過電子技術解決方案以數位格式將下列資訊在產品上清晰可見，或者在不可能的情況下，在其包裝或產品隨附的文件中清晰可見。
a. 製造商、進口商，和歐盟責任人的聯繫地址；
b. 產品識別資訊；
c. 說明和安全資訊。
Economic operators may additionally make the following information in a digital format by means of electronic technical solutions clearly visible on the product or, where that is not possible, on its packaging or in a document accompanying the product.
a. Contact address of manufacturer, importer and EU responsible person;
b. Product identification information
c. Instruction and safety information
線上市場提供商的義務（節選）
Obligations of Providers of online marketplaces (excerpt)
a. 在“安全門門戶”網站上註冊解決產品安全問題的單一聯絡方式。
b. 確保產品安全的內部流程，包括在歐盟設立的製造商或歐盟責任人資訊，以及貿易商承諾僅提供符合本法規的產品的自我證明。
c. 遵循市場監管機構的命令，將提供危險產品的內容從線上介面刪除、禁止訪問或顯示明確警告。
d. 參考市場監管機構定期通報的有關危險產品的資訊，採取自願措施，將提供危險產品的內容從線上介面刪除、禁止訪問或顯示明確警告。
e. 暫停向經常提供不符合本法規產品的貿易商提供服務。
f. 與市場監管機構、貿易商和相關經濟運營商合作，促進為消除或減輕線上產品帶來的風險而採取的任何行動。
a. Register with the Safety Gate Portal for information of single contact point for product safety issues.
b. Ensure the internal processes for product safety, including info. of manufacturer established in the Union or EU responsible person, and self-certification by trader committing to offer only products that comply with this Regulation.
c. Follow order from market surveillance authorities to remove, disable access to or display an explicit warning of content offering a dangerous product from online interface.
d. Apply voluntary measures to remove, disable access to or display on explicit warning of content offering a dangerous product from online interface referring regular information on dangerous products notified by market surveillance authorities.
e. Suspend the provision of their services to traders that frequently offer products which are non-compliant with this Regulation.
f. Cooperate with the market surveillance authorities, with traders and with relevant economic operators to facilitate any action taken to eliminate or mitigate the risks presented by a product offered online.
安全門線上通報機制
Online Notification Mechanism at Safety Gate
安全門由三部分組成：
a. “安全門快速警報系統”是市場監督機構和委員會針對危險非食品產品或小於嚴重風險的產品的內部系統。
b. “安全門門戶”向公眾通報危險產品警報，使消費者能夠提交投訴，並使線上市場提供商能夠將其介面與安全門門戶連結起來。
c. “安全業務閘道”使包括經濟營運商和線上市場提供商在內的企業能夠履行向當局和消費者通報危險產品和事故的義務。
Safety Gate comprises three modules.
a. Safety Gate Rapid Alert System is an internal system of market surveillance authority and commission on dangerous non-food products or products with less than serious risk.
b. Safety Gate Portal informs the public of alerts of dangerous product, enables consumers to submit complaints and enable providers of online marketplaces to link their interfaces with the Safety Gate Portal.
c. Safety Business Gateway enables businesses including economic operator and provider of online marketplaces to comply with their obligation to inform authorities and consumers of dangerous products and accidents.
召回通知
Recall notice
a. 經濟經營者和線上市場提供商以書面形式的召回通知向消費者提供有關產品安全召回的資訊。
b. 召回通知應使用產品上市所在成員國的語言。
c. 召回通知應包括以下內容：
(i) 由“產品安全召回”字樣組成的標題；
(ii) 對召回產品的清晰描述，包括產品圖片、名稱和品牌、產品識別資訊。產品銷售的時間、地點和人員的資訊（如果有）；
(iii) 明確描述與召回產品相關的危害，避免任何可能降低消費者風險感知的因素，例如使用“自願”、“預防性”、“酌情”、“在極少數情況下”或 “在特定情況下”或表明沒有發生事故報告；
(iv) 明確描述消費者應採取的行動，包括立即停止使用召回產品的指示；
(v) 明確說明消費者可以採取的補救措施；
(vi) 免費電話號碼或互動線上服務，消費者可以通過該服務以歐盟相關官方語言獲取更多資訊；
(vii) 如果合適的話，鼓勵與其他人分享有關召回的資訊。
d. 委員會應通過實施法案制定召回通知的範本。
a. Information on a product safety recall is provided to consumers in a written form of a recall- notice by economic operator and providers of online marketplaces.
b. Recall notice shall be in the language(s) of the Member state(s) where the product has been made available on the market.
c. Recall notice shall include the following elements:
(i) A headline consisting of the words “Product Safety recall”
(ii) A clear description of the recalled product including picture, name and brand of the product, product identification info., and info. on when, where and by whom the product was sold if available
(iii) A clear description of the hazard associated with the recalled product avoiding any elements that may decrease consumers’ perception of risk, such as by using terms and expressions such as ‘voluntary’, ‘precautionary’, ‘discretionary’, ‘in rare situations’ or ‘in specific situations’ or by indicating that there have been no reported accidents
(iv) A clear description of the action consumers should take, including an instruction to immediately stop using the recalled product
(v) A clear description of the remedies available to consumers
(vi) A free phone number or interactive online service, where consumers can get more information in relevant official language(s) of the Union
(vii) Encouragement to share the information about the recall with other persons, if appropriate
d. The Commission shall set out the template for a recall notice by implementing act
召回的補救措施
Remedies of recall
a. 補救措施不得給消費者帶來重大不便，例如承擔運輸或退回產品的費用。對於本質上不可攜帶的產品，經濟運營商應安排收集該產品。
(i) 召回產品的維修；
(ii) 用相同類型且至少具有相同價值和品質的安全產品替換召回的產品；或者
(iii) 對召回產品的價值進行足夠的退款，前提是退款金額至少等於消費者支付的價格。
b. 經濟營運商可以只向消費者提供一種補救措施，如其他補救措施是不可能的，或者與擬議的補救措施相比，會給負責產品安全召回的經濟運營商帶來不成比例的成本。
c. 當負責產品安全召回的經濟營運商未能在合理時間內完成維修或更換且未給消費者造成重大不便時，消費者始終有權獲得產品退款。
d. 只有在消費者能夠通過必要的說明、免費更換零件或軟體更新，輕鬆安全地進行維修時，消費者的維修才應被視為有效的補救措施。
e. 消費者對產品的廢棄處理僅應包含在消費者能夠輕鬆安全地進行處置的情況下，並且不應影響消費者獲得退款或更換召回的產品的權利。
f. 補救措施不得給消費者帶來重大不便，例如承擔運輸或退回產品的費用。對於本質上不可攜帶的產品，經濟營運商應安排收集該產品。
a. The economic operator shall offer at least two of the following remedies：
(i) The repair of the recalled product;
(ii) A replacement of the recalled product with a safe one of the same type and at least the same value and quality; or
(iii) An adequate refund of the value of the recalled product, provided that the amount of the refund shall be at least equal to the price paid by the consumer.
b. The economic operator may offer the consumer only one remedy where other remedies would be impossible or, compared to the proposed remedy, would impose costs on the economic operator responsible for the product safety recall that would be disproportionate.
c. The consumer shall always be entitled to a refund of the product when the economic operator responsible for the product safety recall has not completed the repair or replacement within a reasonable time and without significant inconvenience to the consumer.
d. Repair by a consumer shall only be considered an effective remedy where it can be carried out easily and safely by the consumers with the necessary instructions, free replacement parts or software updates.
e. Disposal of the product by consumers shall only be included in the actions to be taken by consumers where such disposal can be carried out easily and safely by the consumer, and shall not affect the right of the consumer to receive a refund for or replacement of the recalled product.
f. The remedy shall not entail significant inconvenience for the consumer, such as bearing the cost of shipping or returning the product. For products that by their nature are not portable, the economic operator shall arrange for the collection of the product.
TÜV SÜD強烈建議客戶儘早採取行動，調整產品的設計和生產要求以符合新法規，以避免產品在2024年12月後因不符合新法規規要求而導致例如滯留海關的風險。
我們的專家團隊助您順利實施新法規，並提供多種符合新法規的解決方案。
如有任何疑問或需要進一步的協助，請隨時與我們聯繫。
It’s highly recommended that customers take actions as early as possible to adapt the design and production requirements of products to the new Regulation so that customers could avoid the risks that products may get stuck in customs etc. due to non-conformity with the new Regulation from Dec. 2024.
Expert teams of TÜV SÜD are glad to support you to adapt to the new Regulation smoothly and provide various solutions for you on conformity of new Regulation.
Should you have any further questions on these topics, please do not hesitate to contact us.
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