Chemically related requirement of medical device

Regulation (EU) 2017/745 (MDR) 

According to Article 52 and 10.4.1 of Annex I of MDR, if devices, or those parts thereof or those materials used therein have met the following anyone of conditions:

• are invasive and come into direct contact with the human body or,
• (re)administer medicines, body liquids or other substances, including gases, to/from the body, or
• transport or store such medicines, body fluids or substances, including gases, to be (re)administered to the body,

Devices, or those parts thereof or those materials used therein shall avoid to contain the following substances above >0.1(w/w)%

• substances which are carcinogenic, mutagenic or toxic to reproduction (‘CMR’), of category 1A or 1B, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 (CLP) of the European Parliament and of the Council, or
• substances having endocrine-disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified either in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (2) or, once a delegated act has been adopted by the Commission pursuant to the first subparagraph of Article 5(3) of Regulation (EU) No 528/2012 of the European Parliament and the Council (3), in accordance with the criteria that are relevant to human health amongst the criteria established therein.

The abovementioned medical device, part or material contains CMR 1A & 1B in CLP or REACH EDCs substances > 0.1% (w/w), then the following action shall be accomplished:

• the presence of those substances shall be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging, with the list of such substances.

• If the intended use of such devices includes treatment of children or treatment of pregnant or breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances and/or materials, information on residual risks for those patient groups and, if applicable, on appropriate precautionary measures shall be given in the instructions for use.

CMR 1A & 1B under CLP and REACH EDCs contain nearly 1,200 substances. SGS only tests relevant High-Risk Substance according to the different classified materials of medical device

Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

EU manufacture, importer, and downstream user are major actors who have to comply with REACH regulation. Therefore non-EU supplier needs to support the above-mentioned actors to comply with REACH obligations. 

SCIP Article notification

On 11th, September 2018 a news was announced by ECHA that was demanded to establish a Substance of Concern in Product database for collecting SVHC information in Article*1 and publishes SVHC related information to waste operator and consumer, more details related to SCIP database can be found below:

Purposes:

• Raising supplier awareness of their obligation
• Raising consumer awareness about substances of high concern (SVHC) in articles
• Provide information to further improve waste treatment operations
• Allow authorities to monitor the use of substances of concern in articles
• Decrease hazardous waste generation by supporting the substitution of substances of concern in articles

 Legal sources:

• REACH regulation (EU) 1907/2006 -Article 33
• Waste Framework Directive (EU) 2018/851- article 9

 Duty holders:

• Duty holder means who places the article or complex object on EU market, for example: 
  EU producers, EU assembler, importers, EU distributors, but not covers actors in supply chain who directly provide the product to consumer.

• According to SCIP FAQ, Non-EU supplier needs to provide the necessary data to EU importer and assist the EU importer to comply with the obligation under REACH. 

 Non-duty holder:

• Actors in supply chain who provides the Article/ complex object directly to consumer, like EU retailer. 

EGULATION (EU) 2019/1021 recast (POPs)

Persistent organic pollutants (POPs) are chemical substances that persist in the environment, bioaccumulate through the various ways, and pose a risk of causing adverse effects to human health and the environment. 

Legal source

• Regulation 850/2004, Regulation 757/2010, Regulation 519/2012, Regulation 2019/1021

 Announced date and entry in force

• Announced date : 2004/4/29 , Entry in force: 2004/5/20

 Product scope

• Substance, Preparation and Article (also including medical device)

 Legal requirements

• Annex 1: 
  Product scope is including substance, preparation and article. There're 28 items in Annex 1 until now. In principle, the use of Annex 1 is prohibited, unless the items have the specific criteria.
• Annex 2: 
  Product scope is including substance, preparation and article. There is no item in Annex 2 until now. In principle, the use of Annex 2 is restricted.

CALIFORNIA PROPOSITION 65

[California proposition 65] is the Safe Drinking Water and Toxic Enforcement Act, simply known as Prop 65 or CP 65. There listed more than 960 chemicals, which cause cancer, birth defects or other reproductive harm, and will update it at least once per year. CP65 requests to do the exposed assessment and put on the warning label.

[California proposition 65] are suitable for all the consumer goods, including textiles, footwear, consumer durables, DIY products, toys, youth products, stationery, electrical/electronic products, etc. CP65 is a consumer "right to know law". Unless exempted, companies must not expose individuals to listed chemical substances without first issuing a "clear and reasonable warning” and cannot discharge the listed chemicals into drinking water sources.

The total amount of the settlement and judgment officially announced in 2019 is about 30 million USD (about 900 million NTD). In the first quarter of 2020, a total of 179 settlements and judgments were officially listed, with total judgments amounting to 2.4 million and 2.6 million US dollars, which is nearly NT$150 million.

EU Packaging and Packaging Waste Directive Service

European Union published Directive on packaging and packaging waste, 94/62/EC in 1994.  Article 6(1) of Directive 94/62/EC sets the targets for recovery and recycling rates at waste packaging. Member States could set more targets for each packaging material of recovery and recycling rates.

On the basis of Directive 94/62/EC Article 11 in paragraph 1, the sum of concentration levels of lead, cadmium, mercury and hexavalent chromium present in packaging or packaging components shall not exceed 100 ppm by weight after 30 June 2001.