Daily News 16 / 08 / 2018

Juncker Plan backs agreement to provides €100 million in loans for small and medium-sized enterprises in Finland

The European Investment Bank (EIB) has concluded an agreement with Tesi, a state-owned investment company, to provide innovative small and medium-sized enterprises in Finland with access to €100 million worth of loans. The agreement was made possible by the support of the Juncker Plan’s European Fund for Strategic Investments (EFSI). As of July 2018, the Juncker Plan is now set to trigger €7.6 billion in investments in Finland and €335 billion across the EU. Vice-President Jyrki Katainen, responsible for Jobs, Growth, Investment and Competitiveness, said: “The Investment Plan’s European Fund for Strategic Investments was designed to facilitate small and medium-sized enterprises gain access to finance they need to expand, innovate and create jobs. So far, around 700,000 small businesses across Europe are expected to benefit. I am delighted that, with today’s transaction, the Investment Plan will allow Finnish firms to benefit from €100 million in financing opportunities.” A full press release can be found here. (For more information: Christian Spahr – Tel.: +32 229 50055; Enda McNamara – Tel.: +32 229 64976)

 

EU releases €2 million in humanitarian assistance to the Philippines

The European Commission has announced €2 million in humanitarian aid funding for the vulnerable communities living in the Philippines’ violence-plagued province of Mindanao. “Hundreds of thousands have been forced to flee their homes due to continued conflict in Mindanao. They left everything behind and are struggling to sustain their day-to-day lives,” said Commissioner for Humanitarian Aid and Crisis Management Christos Stylianides. “This assistance underlines the EU’s solidarity with the people of the Philippines. It will ensure that the most vulnerable have sufficient means to get through these difficult times.” The funding will provide displaced families and host communities affected by the conflict with food assistance, water, sanitation and hygiene, emergency education for children and protection against the pervasive violence. According to the latest data available, at least 500 000 people are currently in need of humanitarian assistance in the region, including more than 270 000 displaced people and some 100 000 out-of-school children. Since 1996, the EU has allocated over €117 million in emergency assistance to victims of conflict and natural disasters in the Philippines. (For more information: Carlos Martin Ruiz De Gordejuela – Tel.: +32 229 65322 ; Daniel Puglisi –  Tel.: +32 229 69140) 

 

Mergers: Commission clears the acquisition of Zeamarine by Maritime Holdings and Zeaborn

The European Commission has approved, under the EU Merger Regulation, the acquisition of joint control over Zeamarine GmbH of Germany by Maritime Holdings (Delaware), LLC of the US and Zeaborn Chartering Management GmbH (“Zeaborn”) of Germany. Zeamarine will be active in general cargo shipping on multi-purpose vessels. Maritime Holdings, controlled by New Mountain Capital of the US, is a provider of ocean transportation services. Zeaborn is an ocean shipping group. The Commission concluded that the proposed acquisition would raise no competition concerns, given the limited impact it would have on the market. The transaction was examined under the simplified merger review procedure. More information is available on the Commission’s competition website, in the public case register under the case number M.8992. (For more information: Ricardo Cardoso – Tel.: +32 229 80100)

Concentrations: la Commission européenne autorise l’acquisition d’Averys par Blackstone

La Commission européenne a approuvé, en vertu du règlement européen sur les concentrations, l’acquisition du groupe Averys, basé en France, par le groupe Blackstone basé aux États-Unis. Averys produit des solutions sur mesure de rayonnage et de stockage pour des entrepôts, sous des marques telles que Stow, Storax, Feralco, Duwic et Acial. Blackstone est un gestionnaire alternatif d’actifs au niveau mondial, qui fournit également des services de conseil financier. La Commission a conclu que l’opération envisagée ne soulèverait pas de problème de concurrence, compte tenu de l’absence de relations horizontales et verticales entre les entreprises. La transaction a été examinée dans la cadre de la procédure simplifiée du contrôle des concentrations. De plus amples informations sont disponibles sur le site internet concurrence de la Commission, dans le registre public des affaires sous le numéro d’affaire M.9045. (Pour plus d’informations: Ricardo Cardoso – Tel.: +32 229 80100)

Eurostat: Excédent de 22,5 milliards d’euros du commerce international de biens de la zone euro

D’après les premières estimations pour le mois de juin 2018, les exportations de biens de la zone euro (ZE19) vers le reste du monde se sont établies à 198,6 milliards d’euros, en hausse de 5,7% par rapport à juin 2017 (187,9 milliards). Les importations depuis le reste du monde ont quant à elles été de 176,1 milliards d’euros, en hausse de 8,6% par rapport à juin 2017 (162,2 milliards). En conséquence, la zone euro a enregistré en juin 2018 un excédent de 22,5 milliards d’euros de son commerce international de biens avec le reste du monde, contre +25,7 milliards en juin 2017. Le commerce intra-zone euro s’est établi à 170,7 milliards d’euros en juin 2018, soit +7,1% par rapport à juin 2017. Un communiqué de presse est disponible en ligne. (Pour plus d’informations: Daniel Rosario – Tél.: +32 229 56185; Kinga Malinowska – Tél: +32 229 51383)

 

 

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Finland: EU funding for growth of Finnish companies

 

  • M-Files A new financing model of the EIB and Tesi will invest EUR 100 million to growth-oriented SMEs and innovative mid-cap companies over the next eight years.
  • Loan backed under European Fund for Strategic Investments, part of successful Juncker Plan

The European Investment Bank (EIB) and the investment company Suomen Teollisuussijoitus Oy Tesi have agreed on a financing programme to channel funding in support of the growth of Finnish companies. The operation is guaranteed under the European Fund for Strategic Investments (EFSI), central pillar of the Investment Plan for Europe of the Juncker Commission. The financing to be managed by Tesi targets a total of EUR 100 million to promising companies, equally split between the EIB and Tesi. Furthermore, the funding  is structured to be complemented by private sector co-investments with another EUR 100 m, totalling EUR 200 m of new investments to the benefit of SMEs and mid-caps.

This financial mechanism supplements EIB funding in the form of equity type investment and equity financing by Tesi. The financing of EUR 15–30 per company is targeted to growth-oriented SMEs and innovative mid-cap companies. In addition, each financing round must involve at least the same amount in private capital. This may be used e.g. to boost growth, internationalisation and product development.

“Finland has succeeded very well in making use of the financial instruments offered by the EU, which is also our Government’s objective. This applies, in particular, to funding from EFSI. The financing programme of Tesi and EIB published today is the first of its kind adopted in the Nordics. It will add to the available sources of risk finance and remove financial bottlenecks faced by growth companies. The programme will significantly boost the growth of innovative growth companies and mid-cap companies that are vital for our national economy and employment”, says Minister of Economic Affairs Mika Lintilä.

“The new financial model enables larger financing rounds than before and diversifies the financing structures of growth-oriented companies. It boosts the growth and internationalisation of companies and improves their ability to make significant investments. We are very happy to partner with EIB and channel equity financing of the EFSI to Finnish companies”, says CEO of Tesi Jan Sasse.

Competitiveness to European companies

Traditionally, the EIB has to large extent offered financing to companies in the form of loans and guarantees, which means that for EIB this is a rather new type of financing. Tesi is EIB’s first partner in the Nordics that channels EFSI-guaranteed financing to companies as direct capital investments.

”I think this operation is one to be proud of.” added EIB vice-president Alexander Stubb. “The platform is designed to fill-in market gaps in the Finnish equity investment landscape, which hinders companies’ development and internationalisation. Two of the priorities under the investment schemes supported by the EU are to support SMEs and to work together with National Promotional Institutions, so I believe we hit the bull’s-eye here.”

The European Fund for Strategic Investment EFSI is part of the Investment Plan for Europe, the Juncker plan. The aim is to secure the access to funding, investments and economic growth for European SMEs.

Jyrki Katainen, Commission Vice-President responsible for Jobs, Growth, Investment and Competitiveness, said: “The Investment Plan’s European Fund for Strategic Investments was designed to facilitate small and medium-sized enterprises gain access to finance they need to expand, innovate and create jobs. So far, around 700,000 small businesses across Europe are expected to benefit. I am delighted that, with today’s transaction, the Investment Plan will allow Finnish firms to benefit from EUR 100 million in financing opportunities.”




How are new medicines approved by EMA?

15/08/2018

Find out what it takes to develop a medicine and to get it authorised

All medicines must be authorised before they can be marketed and made available to patients in the European Union (EU).

When all the relevant information has been collected from laboratory tests and clinical trials, the European Medicine’s Agency’s (EMA) scientific committees conduct a comprehensive scientific evaluation of the data and provide independent recommendations on medicines for human and veterinary use.

If the benefits of the medicine are greater than its risks, EMA gives the green light and recommends to the European Commission that the medicine can be marketed across the EU, as well as in the European Economic Area.

Once the medicine is on the market, the Agency continues to monitor its safety.

For an easy introduction to the evaluation and approval of medicines, watch this video.

For further information, see our webpage on the authorisation of medicines in the EU




How are new medicines approved by EMA?

15/08/2018

Find out what it takes to develop a medicine and to get it authorised

All medicines must be authorised before they can be marketed and made available to patients in the European Union (EU).

When all the relevant information has been collected from laboratory tests and clinical trials, the European Medicine’s Agency’s (EMA) scientific committees conduct a comprehensive scientific evaluation of the data and provide independent recommendations on medicines for human and veterinary use.

If the benefits of the medicine are greater than its risks, EMA gives the green light and recommends to the European Commission that the medicine can be marketed across the EU, as well as in the European Economic Area.

Once the medicine is on the market, the Agency continues to monitor its safety.

For an easy introduction to the evaluation and approval of medicines, watch this video.

For further information, see our webpage on the authorisation of medicines in the EU




Lower concentration limit proposed for PAHs found in granules and mulches

Lower concentration limit proposed for PAHs found in granules and mulches

ECHA/PR/18/12

The Netherlands has prepared a proposal to support a possible restriction to address the risks from eight polycyclic aromatic hydrocarbons (PAHs) found in granules and mulches used in synthetic turf pitches, or in loose forms at playgrounds and other sports facilities.

Helsinki, 16 August 2018 – The proposal, prepared by the Dutch National Institute for Public Health and the Environment (RIVM) in cooperation with ECHA, states that the general concentration limits set under REACH for eight carcinogenic PAHs in mixtures are insufficient for protecting those who come into contact with the granules and mulches while playing at sports facilities and playgrounds.

In its assessment, RIVM looks at the human health risk for professional football players (including goalkeepers), children playing on the pitches and on playgrounds, as well as workers installing and maintaining the pitches and playgrounds.

The proposal suggests a combined concentration limit for the eight PAHs of 17 mg/kg (0.0017 % by weight). The current concentration limits applicable for supply to the general public are set at 100 mg/kg for two of the PAHs and 1 000 mg/kg for the other six.

The proposal of the Netherlands, available on ECHA’s website, outlines that the suggested reduction in the concentration limit would:

  • ensure the cancer risk from PAH exposure remains very low for those coming into contact with the granules and mulches;
  • decrease societal concerns about the negative health impacts caused by the PAHs;
  • lead to no major additional administrative burdens on public authorities in terms of costs for implementing the lower concentration limit; and
  • cause relatively limited and affordable societal costs.

ECHA’s committees will now check whether the restriction dossier conforms to the requirements of REACH. If so, a six-month long consultation will begin in September 2018. ECHA’s scientific committees will assess the proposal and formulate their opinions, and these will be submitted to the Commission.

In addition to processing the Netherlands’ proposal, ECHA will assess – as requested by the European Commission – the health risks of other substances that may be contained in granules and mulches used as infill in synthetic sports pitches. It is possible that ECHA will also assess the environmental risks, too.

Background

In 2017, both ECHA and RIVM assessed the health risks associated with playing sports on synthetic turf pitches where rubber granules are used as infill material.

ECHA concluded in 2017 that there was, at most, a very low level of concern due to the PAHs present in those materials. However, ECHA also gave a number of recommendations to be considered for the future – the first of which was to consider a restriction under REACH to ensure that granules for use as infill material in sports fields are only supplied with very low concentrations of PAHs and of any other relevant hazardous substances.