Bis(2-Ethylhexyl) phthalate (DEHP): max 0.1%:

DIBP is an odorless plasticizer and has excellent heat and light stability. It is the lowest cost plasticizer for cellulose nitrate and is widely used in nitro cellulose plastic, nail polish, explosive material and lacquer manufacturing etc

Benzyl butyl phthalate (BBP): max 0.1%: BBP is a phthalate that is mainly used as an additive for plasticising PVC , perfumes, hair sprays, adhesives, glues, automotive product and vinyl floor coverings etc. At present, BBP is banned in all toys and childcare articles ( European Directive 2005/84/EC) and in cosmetics which includes nail polish as it is considered to be carcinogenic, mutagenic and toxic to reproduction.

Dibutyl phthalate (DBP): max 0.1%: Dibutyl phthalate (DBP) is a commonly used plasticizer and is found naturally in small quantities in cloves. It is soluble in various organic solvents, e. g. in alcohol, ether and benzene and suspected to be an endocrine disruptor. It is also used as an additive to adhesives,printing inks and as an ectoparasiticide (drugs which are used to kill the parasites that live on the body surface).

Diisobutyl phthalate (DIBP): max 0.1%:

DIBP is a phthalate and an additive used to keep plastics soft or more flexible (plasticiser), often in combination with other phthalates.DIBP has very similar properties to DBP which was banned in toys and childcare articles as well as in cosmetics, it may therefore be used as a substitute for instance in PVC, paints, printing inks and adhesives.

Grace Periods are given to DEHP, BBP, DBP and DIBP as they will be restricted from 22 July 2019 for all electrical and electronic equipments apart from medical devices, monitoring and control equipment which will have an additional two years to comply by 22 July 2021.These are chemicals which are added on top of the existing list which consists of the following

Cadmium(Cd): 0.01%;Mercury: 0.1%;Lead(Pb) : 0.1%;Hexavalent chromium (Cr6+) : 0.1%;Polybrominated biphenyls (PBB): 0.1 %;Polybrominated diphenyl ethers (PBDE): 0.1 %.

It shall be noted that above maximum concentration values apply to each homogeneous material rather than a product or a part itself. Here for instance a homogeneous material means material of uniform composition throughout which cannot be mechanically separated into different materials.Some electrical and electronic products are out the scope of EU . Military equipment, large-scale stationary industrial tools, large-scale fixed installations, active implantable medical devices, and photovoltaic panels are excluded from RoHS.Batteries and package materials are also out the scope of RoHS since they are subject to different directives.In addition to that, certain applications are exempt from RoHS restrictions (For example, Cadmium in helium-cadmium lasers).

The post Additional Four Elements – ROHS 2015/863 appeared first on ¿Û¿Û´«Ã½.

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.

The post Amendment to RoHS 2 Directive: Alert for Electronics/Electrical & Medical manufacturers appeared first on ¿Û¿Û´«Ã½.

‘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.

The post Impact of the ROHS2 directive on Medical Device Manufacturers appeared first on ¿Û¿Û´«Ã½.

can be a time-consuming process, but unless it is regularly undertaken companies are liable to make poor decisions. In the engineering field, enterprise data management covers a wide field, ranging from up-to-date client and supplier contact details to records and part obsolescence management. Failure in any of these areas can lead to unwarranted expenses, dissatisfied customers and, in the case of environmental compliance, hefty fines.

How Much Can Poor Data Cost Your Business?

Today, numerous companies offer data cleansing services to electrical and mechanical engineering firms. The solutions we at ¿Û¿Û´«Ã½ Technologies offer are a boon to the small businessman, who is often unable to invest in a dedicated department to take care of things like customer data records and . When you have tight deadlines to meet, it’s hard enough to keep up with your engineering BOMs, let alone work out an effective master data management plan for your company records.

In 2010, at Ovum, a firm of independent technology analysts, reported that businesses are faring badly due to poor master data management – a disaster in today’s economic climate. It was estimated that around $700 billion a year is lost in the US alone, through inefficient upkeep of data files.

The benefits of outsourcing your data cleansing problems to a reputable company are obvious. Battling it through on your own can be a very false economy.

The post Poor Data Cleansing Hampers Business Success, Say Analysts appeared first on ¿Û¿Û´«Ã½.