At the time of adoption of 2011/65/EU directive in 2011, European Commission categorized 4 substances as priority substances to be assessed for next inclusion under RoHS2 restricted substances list. These 4 have now been included and are listed below:

Where are the 4 substances used?

DEHP, BBP, DBP and DIBP are primarily used as Plasticizers to soften PVC (Polyvinyl Chloride). PVC is commonly used for wires and cables and also can be found in some electronic components or plastic parts. Below are the areas where the 4 phthalates are commonly found.

• Cable and Wiring
• Flooring, wall covering and roofing
• Plastic films
• Bags, Brief-case, Gloves, blood bags
• Tablecloth, curtains, shower curtains & similar items
• Headphones
• Water beds & Air mattresses
• Wallpaper/Tapestry coated with PVC
• Footwear
• Bathing equipment
• Accessories on textiles
• Consumer goods packaging
• Car Care products
• Cosmetics (nail polish, hair spray, perfumes)
• Toys and childcare articles
• Paints and Seals
• Sealants and Adhesives
• Lacquer manufacturing
• Environmental pollutant
• Food chain and in the human diet
• Insulation for cables
• Solvent in glow sticks and hydraulic fluids
• Solvent in capacitor dielectric fluids
• Ceramics for electronics
• Building and Construction
• Dialysis equipment, dialysis bags and tubing
• Automotive products
• Food conveyor belts
• Coatings
• Printing inks
• Lubricants
• Plugs and Shock absorbers
• Suspension agent for solids
• Nitro cellulose plastic
• Explosive material

Impact of Directive (EU) 2015/863

The new directive comes in as a release this year, but the substances in question had been already considered to be of hazardous impact since 2011, as per European Commission ().

In the year 2011, European Commission had prioritized the above 4 substances to be analyzed for the next inclusion under . Also the REACH Candidate List by 2011, included DEHP, BBP, DBP and DIBP. Subsequent to these directives, manufacturers took steps to assess the parts and materials that require phthalates substitution from their products thereby reducing the demand for the chemicals in the market and initiating action for removal.

As on date there are very few producers in Europe who manufacture or import these phthalates so the new directive comes in as a second chance for those who still haven’t prepared themselves to avoid these phthalates. EU has now given time till 2019 to implement the restriction.

Thus the impact of the directive will not have an extreme effect but medical device manufacturers will need to give more attention to their product. The relative impact of the directive will also be seen more in case of medical device manufacturers rather than electronic and electrical manufacturers because the application of the above mentioned phthalates is mainly seen in the medical and consumer segment.

This ensures that the impact of the new directive will not be extreme and manufacturers that have REACH SVHC information from their suppliers have a head start. So manufacturers have got enough time to start acting for avoiding these substances.

What manufacturers should do?

EEE manufacturers and their suppliers have over four years to prepare to become compliant to this secondary legislation on RoHS 2. They have to ensure that, in the manufacturing process/ supply chain, these phthalates are not used more than the allowable limit to keep the products compliant to EU’s RoHS 2. As of now most of the manufacturers have collected the RoHS 2 related certificates, supporting documents and also ensured preventive actions or found alternative options to make sure the 6 substances are not present in their products as per the previous requirement of RoHS 2. Now they have to go back and put the same effort to collect the documents and complete the procedures to avoid the new phthalates from the already compliant products.

Most of them have a well-defined compliance management process and in certain cases have engaged with an expert data service provider to do the same, if not it’s the perfect time to make such arrangements. In any case, we would like reiterate that this particular directive will be easier to manage and implement, given that 70% of the market has already taken preventive steps.

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With RoHS 2 directive established, it is important to know what constitutes the documentation for the compliance.  It is impractical for manufacturers to do their own chemical testing at homogenous material level to identify the presence and concentration of restricted chemicals. Instead the most prevalent and advised methodology is to work with the suppliers of the parts to manage compliance and compile evidences by collecting a set of technical documentation.  This methodology is well accepted by industry and all enforcement authorities.

EN 50581:2012 Standard

European Union has published the 50581: 2012 standards to give clarity on the technical documentation required for the assessment of electrical and electronic products with respect to the restriction of hazardous substances.  This standard reconfirms that the methodology of collecting technical documentation from manufacturers of parts is an acceptable mode of handling the compliance process.

What constitutes a technical documentation?

As per the standard, the technical documentation should contain a minimum of the elements outlined below:

• A general description of the product

(This should also assess in which product category it falls under- This evaluation will determine the applicability of certain exemptions available)

• Documents for material, parts and assemblies/sub-assemblies
• Information showing the relationship between technical documents and corresponding material, part, assemblies/sub-assemblies
• List of harmonized standards used to establish technical documentation

What tasks should a manufacturer do?

A manufacturer should do the following task to be and stay in compliance

• He has to determine the information needed for compliance
• Collect the information needed to declare compliance
• Evaluate the information with regard to quality and trustworthiness to include in technical documentation
• Maintain the technical documentation up to date and valid

Implementing each of this step requires clear understanding of process required in each of this stage.  If you are in an industry which got included in RoHS recently,  and implementing this process for the first time in your company, then you should put in necessary  effort to understand applicability of the regulation for each of your product and then implement each of these steps to manage your effectively.

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‘Directive 2011/65/EU’ (RoHS2 recast) focuses on the restriction of the use of certain hazardous substances in electrical and electronic equipment, thereby requiring every manufacturer selling to the EU market to re-evaluate their inventory and ensure compliance with the recast RoHS and WEEE directives.

Medical Device manufacturers are obligated to ensure and demonstrate compliance with the directive. The implications of Non-Compliance to the RoHS2 directive are grave and will prevent the product from carrying a ‘CE’ mark and eventual removal of the product from the market.

In order to demonstrate compliance to the RoHS2 recast, Medical Device Manufacturers are required to

1. Define their product and identify the directives applicable to it
2. Source RoHS compliant material from suppliers & analyse and identify material changes needed to comply with the RoHS2 directive
3. Show proof of compliance to RoHS2 recast by drawing up required technical documentation surrounding their product including conformity risk assessment report, test reports for each part
4. Cite relevant harmonized standards applicable to the device
5. Maintain a register of non-conforming products
6. Provide explanations as to why certain parts do not include test reports
7. Analyze their internal production and implement an appropriate internal production control procedure in line with the recast
8. Draw up an EC declaration of Conformity and affix the ‘CE’ mark on the finished product
9. Be wary of new materials introduced to the medical equipment and ensure that the equipment is tested & re-certified
10. Include a complete evaluation of the product against the list of Restricted Substances by 2014

Medical Device Manufacturers now facing the daunting task of understanding the RoHS2 directive, identifying the rules and regulations impacting their products and providing relevant documentation to demonstrate full compliance. Medical Device Manufacturers have to get comfortable with requirements of RoHS2 directive as fast as they can in order to maintain their competence in EU market.

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It is important that the significance of Children’s play toys are recognized as modern European societies face various economic, social and environmental challenges.

Children’s play toys have a vital role in this modern world. To improve the intellectual and physical growth in children toys are essential. We can even say that toys are the intimate friends of children. Many countries have implemented rigorous safety measures on toys as most of the children who play with these toys are under the age of 5. Compared to adults, children are more sensitive to chemicals and their bodies should never be exposed to hazardous chemicals or materials.

Chemicals are used in toys mainly to make them softer. There are certain chemicals that have been identified as hazardous and they are strictly prohibited from use during the manufacturing processes for toys. Therefore there are regulations created to control and forbid the use of hazardous chemical substances in toys.

In July 1989, the British government adopted the EEC toy safety directive ( 88/378/EEC) and this regulation came in to effect on the 1st of January 1990.This directive ensures that there is free circulation of toys and all these toys are required to have a CE marking along with the name and the address of the first supplier.

In 2012, a final report was prepared for the European Commission, which revealed that some of the member states had argued stating toys, irrespective of whether their primary function uses electrical energy, they are under the scope of RoHS as these toys are under the category 7 of the WEEE Directive. These Member States are known to have considered all toys that use electrical energy to fall under the scope of RoHS. For MS national legislation all EE toys, including the secondary function toys have been under the scope of RoHS and consequently the expectation is that the national requirement may be that all EE toys must be RoHS 2 compliant by January 2013.

The original toy directive that is 88/378/EEC was published in 1988. The EC (European Commission) reviews and updates this directive periodically to ensure that it achieves its objectives. Recent technological developments in the toy industry have raised new issues with regard to the safety of toys in areas such as noise, chemicals, and choking hazards. As a result, a newer EU Toy Safety Directive named 2009/48/EC was introduced to strengthen and update the rules on toy safety. This directive (2009/48/EC) was adopted on May 11 2009 by the European commission and this came into effect on the 20th of July 2011.

Benefits of RoHS EU Toy Safety Directive

RoHS, an environmental directive, is independent from the EU Toy Safety Directive (2009/48/EC) and may be it would apply to all Electrical and Electronic Equipment, but EE toys are definitely included. In its recast, which is known as RoHS 2, the scope extends from toys with a primary electrical function (RoHS, Category 7) to all EE toys, including those whose electrical function is only secondary to the overall play value. For example, a cuddly toy that talks – its primary function as a cuddly toy was exempt by a guidance document from RoHS 1, but now it will fall under the scope of RoHS 2 because it is electrically powered to fulfill this intended function.

Nitrosamines and nitrosatable substances shall be prohibited from use in toys that are intended to be used by children who are under the age of 36 months, or in other toys that are meant to be placed in the mouth if the migration of these substances are equal to or higher than 0.05 mg/kg and 1 mg/kg for nitrosamines and nitrosatable substances respectively.

Although the overall level of in the EU is high, some of the product categories are problematic. According to all enforcement reports, the biggest problem is the presence of lead in imported electrical toys. In proportion to the Commission’s knowledge, the member states will control those activities that are focused on sold equipment and not on components, as the RoHS restrictions apply to the finished product.

The Toy Industry Association supports and facilitates trade between the United States and the European Union. Mutual recognition could address most of the divergences in regulations that would burden companies who sell to both the markets while reinforcing consumer confidence that toys compliant with either standard can be trusted as safe for children. Moreover, establishing a strong regulatory cooperation agreement will ensure a joint U.S. – EU leadership in international regulations.This provides a basis for future trade agreements and also helps to provide a benchmark for the development of other standards pertaining to other countries.

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